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U.S. Department of Health and Human Services

Safety

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Enforcement Report for November 23, 2011

 

November 23, 2011                                                                                        11-47
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Plastic container with paper label, labeled in part: "Publix DELI spinach dip***with spinach, sour cream, water chestnuts, and onions Keep refrigerated. Container is not microwaveable. Net Wt. 16 oz (1 lb) 454g." UPC 41415-00062. Recall # F-0024-2012
CODE
use by date: OCT 10 C1
RECALLING FIRM/MANUFACTURER
Publix Super Markets, Inc., Lakeland, FL, by letter on September 26, 2011. Firm initiated recall is ongoing.
REASON
Product may have been adulterated with Listeria monocytogenes. Consumption of products containing Listeria monocytogenes can cause serious and sometimes fatal infection in young children, frail or elderly people, and others with weakened immune systems.
VOLUME OF PRODUCT IN COMMERCE
59 cases
DISTRIBUTION
FL, SC
___________________________________
PRODUCT
Quick Caf - Thornton's Garden Salad, 6.0 oz. In plastic container with Clear plastic lid. Keep Refrigerated. UPC 73508-83009. Recall # F-0036-2012
CODE
Enjoy BY 09/30/2011; 10/02/2011 & 10/03/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Greencore USA Inc., Newburyport, MA, by email on September 30, 2011.
Manufacturer: Greencore USA Cincinnati Plant, Cincinnati, OH. Firm initiated recall is ongoing.
REASON
The grape tomatoes test positive for Salmonella.
VOLUME OF PRODUCT IN COMMERCE
73/6 oz plastic containers
DISTRIBUTION
IL, IN, KY, OH, TN
___________________________________
PRODUCT
Murray Sugar Free Chocolate Chip Cookies , 5.5 oz . Cookies are in an over wrapped tray package/ 12 per case ). UPC Code 82011-91335. Recall # F-0114-2012
CODE
Date Code (On Case) E04172A6 Date Code (On package) APR1712EA6
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kellogg Co., Battle Creek, MI, by Urgent Allergen Alert on October 13, 2011 and by press release and Website posting on October 14, 2011.
Manufacturer: Kellogg Co., Augusta, GA. Firm initiated recall is ongoing.
REASON
Undeclared pecan allergen found in Murray Sugar Free Chocolate Chip Cookies. The package label does not include pecan as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
12 cases ( 144 pkgs) of 904 cases
DISTRIBUTION
AL, FL, GA, TN
___________________________________
PRODUCT
Fresh & Easy fresh bagged Washed Spinach 12 oz, sold under the "f&e" trademark label. Product labeling reads in part:"f&e***washed spinach***ready to serve or cook***Net wt. 12 oz (340g). Recall # F-0115-2012
CODE
"Enjoy By: OCT 16". Bar coding: 20001124
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresh And Easy, El Segundo, CA, by press release on October 21, 2011.
Manufacturer: Fresh & Easy Campus Produce, Riverside, CA. FDA initiated recall is ongoing.
REASON
Product was confirmed to be positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
2,864 units (at one unit each 12 oz plastic bags)
DISTRIBUTION
AZ, CA, NV
___________________________________
PRODUCT
1) Emporium Packaging and Spice Company Ponchatrain Sauce Mix, Net Wt. 0.17 lb bag. Recall # F-0116-2012;
 
2) Emporium Packaging and Spice Company Ribeye Seasoning, Net Wt. 5 lb boxes.
Recall # F-0117-2012;
 
3) Cafe Paesan All Purpose Seasoning, Net Wt. 1.5 lbs (0.68 kgs.) bottle. 1 case contains 12 bottles. Recall # F-0118-2012;
 
4) (Pedro) Henslee's Durango Texas Style BBQ Seasoning, Net Wt. 1 lb (0.45 kgs.) bottle. Sold as either 15-1 lb containers or 25-1 lb containers. Recall # F-0119-2012
CODE
All codes between 03/01/2011 to 10/25/2011. Example of date code on shipping container: "Oct 25 2011" or "10-25-2011". Individual bottles not lot coded.
RECALLING FIRM/MANUFACTURER
Emporium Packaging & Spice Co., Temple, TX, press release and telephone on October 25, 2011. Firm initiated recall is ongoing,
REASON
The product was manufactured using Yellow No. 5, which was not included in the labeling. The product contained an undeclared milk and soy ingredient.
VOLUME OF PRODUCT IN COMMERCE
Varies for each product.
DISTRIBUTION
TX, UT
___________________________________
PRODUCT
Lean Cuisine Dinnertime Selects Chicken Fettuccini 12 oz Plastic Tray in Fiberboard Carton, UPC Code 0 13800 14880 3. Recall # F-0121-2012
CODE
Lot 125395911G10655, Best Before OCT 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nestle USA, Solon, OH, by letters on October 11, 2011.
Manufacturer: Nestle USA, Inc., Springville, UT. Firm initiated recall is ongoing.
REASON
Allergen alert. The firm received complaints of Lean Cuisine Lemon Garlic Shrimp product was found inside cartons labeled for Lean Cuisine Chicken Fettuccini.
VOLUME OF PRODUCT IN COMMERCE
288 cs/12/12 oz boxes
DISTRIBUTION
FL, WA
___________________________________
PRODUCT
Fairs Oaks Farms Royal Blue, Blue Cheese packed in random weight packages 1/3 to 1/2 lbs in royal blue foil, distributed on or after September 25, 2011. Recall # F-0124-2012
CODE
The product has a day of make sticker 8/3/2011.
RECALLING FIRM/MANUFACTURER
Fair Oaks Dairy Products, LLC, Fair Oaks, IN, by telephone, E-mail letter on October 14, 2011 and by press release on October 19, 2011. FDA initiated recall is ongoing.
REASON
Product found positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
51 lbs
DISTRIBUTION
IN, IL, MI
___________________________________
PRODUCT
Rhythm Superfoods Kale Chips Kool Ranch; Gluten-Free, Vegan, 95% Vitamin A, 55% Vitamin C; USDA Organic, Net Wt. 2.0 oz (57 g) bags; 12 bags per case, UPC: 8 29739 00052 1. Recall # F-0125-2012
CODE
"SELL BY" dates: 03/26/2012, 03/27/2012, 03/28/2012, 04/03/2012, 04/04/2012, and 04/10/2012.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rhythm Superfoods, Austin, TX, by press release on October 28, 2011. 
Manufacturer: Bartush-Schnitzius Foods Co., Lewisville, TX. Firm initiated recall is ongoing.
REASON
Chips containing cashews was inadvertently placed into packaging that did not declare cashews as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
2,754 cases (12 bags/case) = 33,048 bags
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Tuna Salad Sandwiches on White Bread Barcode 767796002679; individually Heat sealed triangle. Recall # F-0126-2012
CODE
All lots sold prior to May 26, 2011; lot code T143
RECALLING FIRM/MANUFACTURER
ACMS, Inc., Sugar Land, TX, by telephone on May 25, 2011 and by hand-delivered letter on May 26, 2011. FDA initiated recall is ongoing.
REASON
The product contains undeclared egg.
VOLUME OF PRODUCT IN COMMERCE
12 Sandwiches
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Individual size pineapple coconut pies labeled in part: "BRIDGE CITY BAKING FRESH BAKED HAND PIES***gluten free***Net wt 4.5 oz (128g) INGREDIENTS: ***GLUTEN FREE FLOUR; GARBANZO FLOUR, POTATO STARCH, TAPIOCA FLOUR***CREAM CHEESE (PASTURIZED MILK)***ALLERGENS: ADE IN A FACILITY WHERE PRODUCTS CONTAINING MILK, SOY, PEANUTS AND TREE NUTS ARE PRESENT.” Recall # F-0127-2012;
 
2) Individual size blueberry pies labeled in part: "BRIDGE CITY BAKING FRESH BAKED HAND PIES***gluten free***Net wt 4.5 oz (128g) INGREDIENTS: ***GLUTEN FREE FLOUR; GARBANZO FLOUR, POTATO STARCH, TAPIOCA FLOUR***CREAM CHEESE (PASTURIZED MILK)***ALLERGENS: ADE IN A FACILITY WHERE PRODUCTS CONTAINING MILK, SOY, PEANUTS AND TREE NUTS ARE PRESENT.” Recall # F-0128-2012 ;
 
3) Individual size French apple pies labeled in part: "BRIDGE CITY BAKING FRESH BAKED HAND PIES***gluten free***Net wt 4.5 oz (128g) INGREDIENTS: ***GLUTEN FREE FLOUR; GARBANZO FLOUR, POTATO STARCH, TAPIOCA FLOUR***CREAM CHEESE (PASTURIZED MILK)***ALLERGENS: ADE IN A FACILITY WHERE PRODUCTS CONTAINING MILK, SOY, PEANUTS AND TREE NUTS ARE PRESENT", Recall # F-0129-2012
CODE
The manufacturer does not code the product; stores that sell the product may put a sell by date on them. Products are given a 3 day or 6 day expiration date depending on whether they are displayed "dry" (i.e. ambient temp.) or refrigerated.
RECALLING FIRM/MANUFACTURER
Bridge City Baking LLC, Portland, OR, by telephone on March 28, 2011 and a press release on April 1, 2011. Oregon initiated recall is ongoing.
REASON
Product contains undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
OR
_____________________________________
PRODUCT
Now Brewer's Yeast Tablets, 10 Grain, 650 mg; a dietary supplement; packaged in plastic bottles, 200 tablets /12 bottles per case – 1) item 2410 - UPC 7 33739 02410 7, and 500 tablets/10 bottles per case – 2) item 2412 - UPC 7 33739 02412 1; Serving Size 3 tablets; The tablets were also sold under the following labels: a) Nature's Wonderland Brewer's Yeast; 500 tablet bottles, 3) item V27, UPC 7 15486 90270 9; b) Now Brewer's Yeast Tablets, 10 Grain, 650 mg; 200 tablet bottles; 4) item V221 2410 - UPC 7 33739 10015 3. Recall # F-0142-201
CODE
1) Lot numbers 1334119, 1354098 and 1362375; 2) lot numbers 1334773, 1347607and 1358774; 3) lot number 1363652; 4) lot numbers 1335371 and 1358420
RECALLING FIRM/MANUFACTURER
Recalling Firm: NOW Foods, division of The Fruitful Yield, Inc., Bloomingdale, IL, by press release on October 12, 2011,
Manufacturer: Kabco Pharmaceuticals, Inc., Amityville, NY. FDA initiated recall is ongoing.
REASON
The Brewer's Yeast Tablets contain an undeclared milk allergen (whey protein).
VOLUME OF PRODUCT IN COMMERCE
20,106 - 200 tablet bottles, 3,273 - 500 tablet bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Rice-A-Roni Rice Pilaf Flavor, Family Size ; a light mix of tender rice, pasta, herbs and seasonings; Net Wt. 10.8 oz (306 g) box, 12 boxes per case; UPC 15300 43004. Recall # F-0170-2012
CODE
Best Before JUL 30 12 B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Quaker Foods and Snacks North America, Chicago, IL, by press release on November 5, 2011.
Manufacturer: Quaker Foods and Snacks, Bridgeview, IL. Firm initiated recall is ongoing.
REASON
The Rice-A-Roni Family Size Rice Pilaf contains an undeclared milk allergen.
VOLUME OF PRODUCT IN COMMERCE
826 cases
DISTRIBUTION
CA, AZ
 
RECALLS AND FIELD CORRECTIONS: COSMETICS - CLASS II
__________________________________
PRODUCT
John Frieda Sheer Blonde Highlight Activating Enhancing Conditioner for Lighter Shades 8.45 fl. Oz. Flexible tubes, 6 units per case. 1) Item #, 1171605, Tube UPC, 7 17226 50513 3, Case UPC , 107 17226 50513 0; 2) Item #, 1171605, Tube UPC, 7 17226 50513 3, Case UPC, 107 17226 50513 0. Recall # F-0001-2012
CODE
1) Lot Code, A126126ZZ; 2) Lot Code, A126226ZZ
RECALLING FIRM/MANUFACTURER
KAO Brands, Co., Cincinnati, OH, by letters on August 11, 2011. Firm initiated recall is ongoing.
REASON
Product erroneously shipped to customers during transfer for destruction. Product had been rejected, quarantined, and blocked by Quality Services due to microbial contamination. Micro results were above specification limits of: Less than 100 cfu/grams. Results range from 120 cfu/gram to 210 cfu/gram.
VOLUME OF PRODUCT IN COMMERCE
718 cs/6/8.45 fl oz tubes
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
_________________________________
PRODUCT
Baked Naturals Sesame Sticks 20% More! Net Weight 10.2 oz (289g), bag in carton, UPC 0 14100 09725 9. Recall # F-0032-2012
CODE
SELL BY 11/20/2011, WO7A1781; SELL BY 11/20/2011, WO7P1781; SELL BY 11/27/2011, WO7A1891; SELL BY 11/27/2011, WO7P1891; SELL BY 12/4/2011, WO7A1921; SELL BY 12/4/2011, WO7P1921; SELL BY 12/11/2011, WO7N2041; SELL BY 12/11/2011, WO7A2041; SELL BY 12/11/2011, WO7P2041; SELL BY 12/13/2011, WO7A2061; SELL BY 12/13/2011, WO7P2061; SELL BY 1/1/2012, WO7A2221 and SELL BY 1/1/2012, WO7P2221
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pepperidge Farm, Inc., (Manufacturing Location), Norwalk, CT, by letters and press release on September 22, 2011.
Manufacturer: Pepperidge Farm Inc., Willard, OH. Firm initiated recall is ongoing.
REASON
The firm received complaints of small wire fragments in the product.
VOLUME OF PRODUCT IN COMMERCE
10,011cs/20/10.2 oz (289g) bags + 20 bulk containers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Optim3 the Ultimate Enzyme Formula with Tumeric 1000 mg 90 ct/150 ct, 12 bottles per box, item numbers: 63779-90 and 63779-150. Recall # F-0072-2012
CODE
Lot #10338
RECALLING FIRM/MANUFACTURER
Creation's Garden Natural Products Inc., Valencia, CA, by letter on April 28, 2011. Firm initiated recall is ongoing.
REASON
Turmeric Powder, supplied from San Francisco Herb & Natural Food Company indicated elevated levels of lead.
VOLUME OF PRODUCT IN COMMERCE
1,136 bottles
DISTRIBUTION
AZ
___________________________________
PRODUCT
12" spinach wrap. The product label reads in part: "LA CANASTA TORTILLAS***12" Spinach Wrap***5/1 dz". UPC code: 0 34392 10258 5. Recall # F-0130-2012
CODE
best by dates: 1121111, 1128111, 1207111, 1214111
RECALLING FIRM/MANUFACTURER
La Canasta Mexican Foods Inc., Phoenix, AZ, by telephone, e-mails and visits on September 22, 2011. FDA initiated recall is ongoing.
REASON
Undeclared FD&C Yellow # 5 and Blue # 1 food coloring.
VOLUME OF PRODUCT IN COMMERCE
285 cases at 5/1 dz per case
DISTRIBUTION
AZ
___________________________________
PRODUCT
Blue Bunny Personals Ice Cream, Peanut Butter Panic, packaged in 5.5 fl. oz. personal sized containers, UPC 0 70640 00463. Recall # F-0131-2012
CODE
Lot #10009, Best Used By 10/1/2012
RECALLING FIRM/MANUFACTURER
Wells Enterprises, Inc., Le Mars, IA, by telephone between October 26-27, 2011 and by press release on October 27, 2011 and letters dated October 27, 2011. Firm initiated recall is on going.
REASON
The product contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
22,584/5.5-fl. oz. containers
DISTRIBUTION
FL, IA, IN, KS, MA, MN, MO, MS, ND, NE, OK, OR, PA, TN, TX, and WI
___________________________________
PRODUCT
Brand: MuscleLink; Product: Cort-Bloc Size: 60 capsules per bottle. Recall # F-0132-2012
CODE
Lot: 105170 JUN/14
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ironman, Oxnard, CA, by letter on October 19, 2011.
Manufacturer: Treadcorp Ltd., Middletown, CA. Firm initiated recall is ongoing.
REASON
Product contains peptide bonded glutamine that fails to declare wheat as an allergen.
VOLUME OF PRODUCT IN COMMERCE
1,236 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Weis Markets from the Field Whole Mandarin Orange Segments in Light Syrup, 11 oz. Recall # F-0133-2012
CODE
W69 01 601 Best by Dec/02/2012 4200/01033
RECALLING FIRM/MANUFACTURER
Recalling Firm: Weis Markets Inc., Sunbury, PA, by e-mail on March 30, 2011.
Manufacturer: Hubei Xinshiji Foods Co., LTD, Dangyang, China. Firm initiated recall is ongoing.
REASON
Several cans were found to be leaking.
VOLUME OF PRODUCT IN COMMERCE
1,345 units
DISTRIBUTION
MD, NJ, NY, PA, WV
___________________________________
PRODUCT
1) Jumpin' Jack brand Cheese, Raw Milk, Semi-Soft, labeled in part ***MOUNTAlN VIEW FARM PRODUCTS Farmstead Cheese Permit #51-265427 FRESH FROM THE FIELD Jumpin' Jack Semi-Soft Cheese INGREDIENTS: RAW MILK, CULTURE, RENNETT, AND SEA SALT. Recall # F-0137-2012
 
2) Cheese, Gouda Style, Raw Milk, Semi-Soft sold under the following brand names: 1) Lusk, MOUNTAlN VIEW FARM PRODUCTS Farmstead Cheese Permit #51-265427 FRESH FROM THE FIELD Jumpin' Jack Semi-Soft Cheese INGREDIENTS: RAW MILK, CULTURE, RENNETT, AND SEA SALT*** 2) Marmac brand Cheese, Gouda Style, Raw Milk, Semi-Soft, MOUNTAlN VIEW FARM PRODUCTS Farmstead Cheese Permit #51-265427 FRESH FROM THE FIELD Jumpin' Jack Semi-Soft Cheese INGREDIENTS: RAW MILK, CULTURE, RENNETT, AND SEA SALT. Recall # F-0138-2012
CODE
1) Lot 193-11, use by 11/9;
2) Lot 186-11, use by 11/2; 2) Lot 185-11, use by 11/1
RECALLING FIRM/MANUFACTURER
Mountain View Farm Products, LLC, Fairfield, VA, by telephone and letter over the time period of September 30, 2011 through October 5, 2011. Firm initiated recall is ongoing.
REASON
Product shipped before the end of the 60 day aging process.
VOLUME OF PRODUCT IN COMMERCE
212 pounds
DISTRIBUTION
VA
___________________________________
PRODUCT
Mazelle's Key Lime Margarita Original Cheesecake; Mazelle's DESSERTS Desserts your guest come back for INGREDIENTS: Cream cheese (pasteurized milk and cream, cheese culture, salt, carob bean gum), frozen egg yolks (whole eggs, egg yolks, corn syrup, dextrim), flour, (bleached wheat flour, niacin mononitrate, riboflavin, folic acid, enzyme), brown sugar (sugar, molasses, invert syrup), almonds carrageenan, mono and diglycerides, cellulose gum, polysorbate 80, standarized with dextrose), salt, lemon juice, cinnamon, salt. MAY CONTAIN ONE OR MORE OF THE FOLLOWING: KEY LIME MARGARITA (5.5 LBS., 2.5 KG): Key lime juice (lime juice, 1/10 of 1% sodium benzoate). Packaged as 2 units per case. Recall # F-0139-2012
CODE
01/11-04/11. MFG #10205
RECALLING FIRM/MANUFACTURER
Cheesecake Royale, Inc., Dallas, TX, by telephone and letter dated April 8, 2011. FDA initiated recall is ongoing.
REASON
The product contains undeclared Yellow # 5.
VOLUME OF PRODUCT IN COMMERCE
40 cakes
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Frozen Chocolate Chip .625 oz, 1.25 oz., 2.0 oz., 3.0 oz., 4.5 oz., 5.0 oz.,10.0 oz., and 2) 500. Recall # F-0150-2012;
 
2) Frozen Double Fudge 0.625 oz.,1.25 oz., 2.0 oz., 3.0 oz., 4.5 oz., and 5.0 oz. Recall # F-0151-2012;
 
3) Frozen M&M 1.25 oz., 2.0 oz., and 3.0 oz. Recall # F-0152-2012;
 
4) Frozen Mac Nut White Chocolate Chip 0.625 oz, 1.25 oz, 2.0 oz, and 3.0 oz. Recall # F-0153-2012;
 
5) Frozen Oatmeal Chocolate Chip 3.0 oz. Recall # F-0154-2012;
 
6) Frozen Oatmeal Raisin 1) 0.625 oz, 1.25 oz, 2.0 oz, 3.0 oz, 4.5 oz, 5 oz., and 2) 500. Recall # F-0155-2012;
 
7) Frozen Peanut Butter 1.25 oz, 2.0 oz, 3.0 oz. Recall # F-0156-2012;
 
8) Frozen Snickerdoodle 1.25 oz, 2.0 oz, 3.0 oz. Recall # F-0157-2012
 
9) Frozen Sugar 0.625 oz,1.25 oz, 2.0 oz, 3.0 oz. Recall # F-0158-2012;
 
10) FZ SC Chocolate Chip 1.25 oz, 1.25 oz (Whole Wheat), 2.0 oz, 2.5 oz. Recall # F-0159-2012;
 
11) FZ SC Oatmeal Raisin 2.0 oz, 3.0 oz. Recall # F-0160-2012
CODE
1) -11) Lot # SA102611
RECALLING FIRM/MANUFACTURER
Sweet Life Enterprises, LLC, Santa Ana, CA, by letter on October 26, 2011. Firm initiated recall is ongoing.
REASON
The pre-portioned frozen cookie dough has undeclared soy allergen.
VOLUME OF PRODUCT IN COMMERCE
18,172 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
King's Supermarket brand Turkey Gravy 20 oz and 32 oz retail cup pack sizes. 
Recall # F-0166-2012
CODE
32 oz retail cup Lot Number: 1027117D Use or Freeze By: 12/16/2011 20 oz retail cup Lot Number: 0912119D Use or Freeze By: 11/1/2011
RECALLING FIRM/MANUFACTURER
Blount Seafood Corporation dba Blount Fine Foods, Fall River, MA, by telephone, email on November 7, 2011. Firm initiated recall is ongoing.
REASON
The product contains undeclared hydrolyzed soy protein.
VOLUME OF PRODUCT IN COMMERCE
429 cases, 3,432 units (cups)
DISTRIBUTION
NJ
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
Old Label:***Wegmans diet Orange FLAVORED SODA WITH OTHER NATURAL FLAVORS 67.6 fl oz (2 qt 3.6 fl oz) 2 Liter***Ingredients: Carbonated Water, Citric Acid, Potassium Citrate, Natural Flavor, Aspartame, Potassium Benzoate (a preservative), Gum Acacia, Yellow 6, Acesulfame Potassium, Ester Gum, Salt, Brominated Vegetable Oil, Red 40. Product of Canada Caffeine Free New Label: ***Wegmans diet Orange FLAVORED SODA WITH OTHER NATURAL FLAVORS 67.6 fl oz (2 qt 3.6 fl oz) 2 LITER***Ingredients: Carbonated Water, Citric Acid, Potassium Citrate, Natural Flavor, Aspartame, Potassium Benzoate (a preservative), Gum Acacia, Yellow 6, Acesulfame Potassium, Ester Gum, Salt, Brominated Vegetable Oil, Red 40. PHENYLKETONURICS: CONTAINS PHENYLALANINE Product of Canada Caffeine Free. Recall # F-0136-2012
CODE
Use By: 093010,102110, 102810, 110310, 111010, 120810, 123010, 012611 and 021611
RECALLING FIRM/MANUFACTURER
Cott Beverages Canada, a division of Cott Corp., Mississauga, Canada, by letter on October 6, 2010. Firm initiated recall is ongoing.
REASON
The label on the bottle does not contain the Phenylketonuric (PKU) warning. The product is marked as a diet product and aspartame is included in the ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
10011 cases
DISTRIBUTION
NY, VA, NJ, MD and PA
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report17, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
 
No early postings this week.
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
1) N-Acetyl-Cysteine, 600 MG, CAPSULE, NDC 27434-0002-11. Recall # D-002-2012;
 
2) Nadolol, 20 MG, TABLET, a) NDC 00093-4235-01, b) NDC 00781-1181-01. Recall #
D-003-2012;
 
3) Nadolol, 40 MG, TABLET, NDC 00781-1182-01. Recall # D-004-2012;
 
4) Naltrexone HCl, 50 MG, TABLET, a) NDC 00406-1170-03, b) NDC 00555-0902-01, c) 00555-0902-02. Recall # D-005-2012;
 
5) Naproxen, 250 MG, TABLET, a) NDC 00093-0147-05, b) NDC 00904-6069-40. Recall # D-006-2012;
 
6) Naproxen, 500 MG, TABLET, a) NDC 00378-0451-05, b) NDC 53746-0190-01, c) NDC 53746-0190-05, d) NDC 53746-0190-10. Recall # D-007-2012;
 
7) NAPROXEN SODIUM, 220 MG, TABLET, a) NDC 00904-5229-51, b) NDC 00904-5229-59, c) NDC 00904-5230-59. Recall # D-008-2012;
 
8) Naproxen Sodium, 275 MG, TABLET, NDC 00093-0536-01. Recall # D-009-2012;
 
9) Naproxen Sodium, 550 MG, TABLET, NDC 53746-0194-01. Recall # D-010-2012;
 
10) Nateglinide, 120 MG, TABLET, a) NDC 00078-0352-05, b) NDC 49884-0985-01, c) NDC 55111-0329-90. Recall # D-011-2012;
 
11) Nateglinide, 60 MG, TABLET, a) NDC 49884-0984-01, b) NDC 55111-0328-90. Recall # D-012-2012;
 
12) Nebivolol, 10 MG, TABLET, NDC 00456-1410-30. Recall # D-013-2012;
 
13) Nebivolol, 2.5 MG, TABLET, NDC 00456-1402-30. Recall # D-014-2012;
 
14) Nebivolol, 5 MG, TABLET, a) NDC 00456-1405-01, b) NDC 00456-1405-30. Recall # D-015-2012;
 
15) Nefazodone HCl, 100 MG, TABLET, NDC 00093-1024-06. Recall # D-016-2012;
 
16) Nefazodone HCl, 150 MG, TABLET, NDC 00093-7113-06. Recall # D-017-2012;
 
17) Nefazodone Hydrochloride, 200 MG, TABLET, NDC 00093-1025-06. Recall # D-018-2012;
 
18) Neomycin Sulfate, 500 MG, TABLET, NDC 00093-1177-01. Recall # D-019-2012;
 
19) Nephro-Vite RX, TABLET, NDC 52544-0977-01. Recall # D-020-2012;
 
20) Niacin, 100 MG, TABLET, NDC 54629-0071-01. Recall # D-021-2012;
 
21) Niacin 250 MG, CAPSULE, NDC 00536-4074-01. Recall # D-022-2012;
 
22) Niacin, 50 MG, TABLET, NDC 00904-2270-60. Recall # D-023-2012;
 
23) Niacin, 500 MG, TABLET, a) NDC 00182-4405-01, b) NDC 00904-2272-60. Recall # D-024-2012;
 
24) Niacin CR, 500 MG, TABLET, NDC 00245-0063-11. Recall # D-025-2012;
 
25) Niacin ER, 1000 MG, TABLET, a) NDC 00074-3080-90, b) NDC 00536-7038-01. Recall # D-026-2012;
 
26) Niacin ER, 500 MG, CAPSULE, a) NDC 00536-4077-01, b) NDC 00536-4077-01, c) NDC 00904-0631-60. Recall # D-027-2012;
 
27) Niacin ER, 1000 MG, TABLET, a) NDC 00074-3080-90, b) NDC 00536-7038-01. Recall # D-028-2012;
 
28) Niacin ER, 750 MG, TABLET, NDC 00074-3079-90. Recall # D-029-2012;
 
29) Niacin Extended Release, 500 MG, TABLET, a) NDC 00074-3074-90, b) NDC 00536-7030-01, c) NDC 00904-4342-60. Recall # D-030-2012;
 
30) Niacin-SR, 250 MG, CAPSULE, NDC 00603-4736-21. Recall # D-031-2012;
 
31) NiCARdipine, 20MG, CAPSULE, NDC 00378-1020-77. Recall # D-032-2012;
 
32) Nicardipine HCl, 30 MG, CAPSULE, NDC 00378-1430-77. Recall # D-033-2012;
 
33) Nicotine, 2 MG, LOZENGE, a) NDC 00113-0344-03, b) NDC 00766-1500-10, c) NDC 49348-0852-16. Recall D-034-2012;
 
34) Nicotine, 4 MG, LOZENGE, a) NDC 00113-0873-03, b) NDC 49348-0853-16. Recall # D-035-2012;
 
35) Nicotine Polacrilex, 2 MG, GUM, a) NDC 00536-3029-23, b) NDC 00904-5734-51, c) 37205-0203-77. Recall # D-036-2012;
 
36) Nifedepine, 20 MG, CAPSULE, NDC 00228-2530-10. Recall # D-037-2012;
 
37) NIFEdipine, 10 MG, CAPSULE, a) NDC 00069-2600-66, b) NDC 00228-2497-10, c) NDC 43386-0440-24. Recall # D-038-2012;
 
38) Nifedipine, 20 MG, CAPSULE, NDC 00228-2530-10. Recall # D-039-2012;
 
39) NIFEdipine ER, 30 MG, TABLET, a) NDC 00093-0819-01, b) NDC 00378-0480-01. Recall # D-040-2012;
 
40) Nifedipine ER, 60 MG, TABLET, a) NDC 00093-1022-01, b) NDC 00093-5173-01. Recall # D-041-2012;
 
41) Nifedipine ER, 90 MG, TABLET, NDC 62175-0262-37. Recall # D-042-2012;
 
42) Nisoldipine ER, 40 MG, TABLET, NDC 00378-2224-01. Recall # D-043-2012;
 
43) Nisoldipine ER, 8.5 MG, TABLET, a) NDC 00378-2096-01, b) NDC 00677-1978-01. Recall # D-044-2012;
 
44) Nitrofurantoin, 25 MG/5 ML, ORAL SOLUTION in a CUP, NDC 59630-0450-08. Recall # D-045-2012;
 
45) Nitrofurantoin Macrocrystals, 25 MG, CAPSULE, NDC 00149-0007-05. Recall # D-046-2012;
 
46) Nitrofurantoin Mono/Macro 100 MG, CAPSULE, a) NDC 00149-0710-01, b) NDC 00185-0122-01, c) NDC 00378-3422-01. Recall # D-047-2012;
 
47) Nitroglycerin Slocap, 9 MG, CAPSULE, NDC 00185-1217-01. Recall #D-048-2012;
 
48) Nitroglycerin SR, 6.5 MG, CAPSULE, a) NDC 00185-1235-01, b) NDC 00904-0644-60. Recall # D-049-2012;
 
49) Nitroglycerin Sustained Release, 2.5 MG, CAPSULE, a) NDC 00185-5174-01, b) NDC 00904-0643-60. Recall #D-050-2012;
 
50) Norethindrone Acetate, 5 MG, TABLET, NDC 00555-0211-10. Recall # D-051-2012;
 
51) Norfloxacin, 400 MG, TABLET, NDC 00006-0705-20. Recall # D-052-2012;
 
52) Nortriptyline HCl, 10 MG, CAPSULE, NDC 00093-0810-01. Recall # D-053-2012;
 
53) Nortriptyline HCl, 25 MG, CAPSULE, NDC 00093-0811-01. Recall # D-054-2012;
 
54) Nortriptyline HCl, 50 MG, CAPSULE, NDC 00591-5788-01. Recall # D-055-2012;
 
55) Nortriptyline HCl, 75 MG, CAPSULE, a) NDC 00093-0813-01, b) NDC 00591-5789-01. Recall # D-056-2012;
 
56) Nystatin, 500,000 UNITS, TABLET, NDC 00093-0983-01. D-057-2012;
 
57) Nystatin Oral Suspension in a CUP, 100,000 U/ML, NDC 00603-1481-58. D-058-2012;
 
58) Ocuvite Lutein, TABLET, a) NDC 24208-0378-62, b) NDC 24208-0387-60, c) 24208-0387-62. Recall # D-059-2012;
 
59) OLANZapine, 2.5 MG, TABLET, NDC 00002-4112-30. Recall # D-060-2012;
 
60) OLANZapine, 20 MG, TABLET, NDC 00002-4420-30. Recall # D-061-2012;
 
61) Olanzapine, 5 MG, TABLET, NDC 00002-4115-30. Recall # D-062-2012;
 
62) Olanzapine, 7.5 MG, TABLET, NDC 00002-4116-30. Recall # D-063-2012;
 
63) Olmesartan Medoxomil, 20 MG, TABLET, NDC 65597-0103-30. Recall # D-064-2012;
 
64) Olmesartan Medoxomil, 5 MG, TABLET, NDC 65597-0101-30. Recall # D-065-2012;
 
65) Olsalazine Sodium, 250 MG, CAPSULE, NDC 68220-0160-10. Recall # D-066-2012;
 
66) Omega-3 Fatty Acid, 500 MG, CAPSULE, NDC 00904-5604-13. Re) call # D-067-2012;
 
67) Omega-3 Fish Oil, 1000 MG, SOFTGEL, a) NDC 00904-4043-60, b) NDC 00904-4604-13, c) NDC 04746-9040-40, d) NDC 05445-8000-22, e) NDC 11845-0144-79, f) NDC 11845-0149-51, g) NDC 30768-0037-81, h) NDC 31184-5149-51, i) NDC 40985-0228-73, j) NDC 54458-0000-22, k) NDC 54629-0069-00, l) NDC 54629-0893-03, m) NDC 54629-0893-09, n) NDC 79854-0008-93. Recall # D-068-2012;
 
68) Omega-3-Acid Ethyl Esters, 1 GRAM, CAPSULE, a) NDC 00173-0783-02, b) NDC 00173-0783-03. Recall # D-069-2012;
 
69) Omega-3-Omega-6 Fatty Acid, 1200 MG, SOFTGEL, NDC 00536-7186-01, 31604-0013-14, 31604-0013-28, 31604-0013-58. Recall # D-070-2012;
 
70) Omeprazole DR, 10 MG, capsule, a) NDC 00378-5211-93, b) NDC 62175-0114-32. Recall # D-071-2012;
 
71) Omeprazole DR, 10 MG, CAPSULE, a) NDC 00378-5211-93, b) NDC 62175-0114-32. Recall # D-072-2012;
 
72) Omeprazole DR 20 mg Capsule, a) NDC 00378-6105-10, b) NDC 00378-6150-10, c) NDC 62175-0118-37. Recall # D-073-2012;
 
73) Ondansetron Hydrochloride, 4 MG, TABLET, a) NDC 00093-0233-56, b) NDC 00143-2422-30 . Recall # D-074-2012;
 
74) Ondansetron HCl, 4 MG/5 ML, LIQUID in a CUP, NDC 50111-0819-42. Recall # D-075-2012;
 
75) Ondansetron ODT, 4 MG, TABLET, a) NDC 00093-7301-65, b) NDC 00378-7732-93, c) 62756-0240-64. Recall # D-076-2012;
 
76) Orphenadrine Citrate ER, 100 MG, tablets, NDC 00185-0022-01. Recall # D-077-2012;
 
77) OXcarbazepine, 150 MG, TABLET, a) NDC 51991-0292-01, b) NDC 62756-0183-88. Recall # D-078-2012;
 
78) Oxcarbazepine, 300 MG, TABLET, NDC 62756-0184-88. Recall # D-079-2012;
 
79) Oxcarbazepine, 300 MG/5 ML, SUSPENSION in a CUP, a) NDC 00078-0357-52, b) NDC 00781-6270-43. Recall # D-080-2012;
 
80) Oxybutynin Chloride, 5 MG, TABLET, NDC 50111-0456-03. Recall # D-081-2012;
 
81) Oxybutynin Chloride ER, 10 MG, TABLET, a) NDC 00093-5207-01, b) NDC 00378-6610-01. Recall # D-082-2012
 
82) Oxybutynin Chloride ER, 15 MG, TABLET, NDC 00093-5208-01. Recall # D-083-2012;
 
83) Oxybutynin Chloride ER, 5 MG, TABLET, a) NDC 00378-6605-01, b) NDC 62175-0270-37. Recall # D-084-2012;
 
84) Paliperidone ER, 9 MG, TABLET, NDC 50458-0552-01. Recall # D-085-2012;
 
85) Pancrease MT, 10, CAPSULE, NDC 00045-0342-60. Recall # D-086-2012;
 
86) Nabumetone, 500 MG, TABLET, NDC 00185-0145-01. Recall # D-087-2012;
 
87) Nabumetone, 750 MG, TABLET, a) NDC 00185-0146-01, b) NDC 68462-0359-01. Recall # D-088-2012;
 
88) Pancrelipase, 16800/70000/40000 USP UNITS, CAPSULE, NDC 50458-0343-60. Recall # D-089-2012;
 
89) Pancrelipase DELAYED RELEASE, 6000/19000/30000 USP CAPSULES, a) NDC 00032-1206-01, b) NDC 00032-1206-07. Recall # D-090-2012;
 
90) Pancrelipase DR, 12000/38000/60000 USP UNITS, CAPSULE, a) NDC 00032-1212-01, b) NDC 00032-1212-07. Recall # D-091-2012;
 
91) Pancrelipase DR, 24000/76000/120000 USP UNITS, CAPSULE, a) NDC 00032-1224-01, b) NDC 00032-1224-07. Recall # D-092-2012;
 
92) Pancrelipase DR, 4,200/17,500/10,000 UPS UNITS, CAPSULE, NDC 50458-0341-60. Recall # D-093-2012;
 
93) Pancrelipase DR, 5000/27000/17000 USP, CAPSULE, a) NDC 03982-2020-51, b) NDC 39822-0205-01. Recall # D-094-2012;
 
94) Pantoprazole Sodium DR 20 MG, TABLET, NDC 00378-6688-77, b) NDC 55111-0332-90. Recall # D-095-2012;
 
95)Pantoprazole Sodium DR 40 MG, TABLET, a) NDC 00008-0607-01, b) NDC 00008-0841-81, c) NDC 00093-0012-98, d) NDC 00378-6689-10, e) NDC 00378-6689-77, f) NDC 621 75-0181-46. Recall # D-096-2012;
 
96) Paricalcitol 1 MCG CAPSULE, NDC 00074-4317-30. Recall # D-097-2012;
 
97) PARoxetine, 10 MG, TABLET, a) NDC 00093-7114-98, b) NDC 00378-7001-93, c) NDC 59762-1808-01, d) NDC 65862-0154-30. Recall # D-098-2012;
 
98) PARoxetine, 20 MG, TABLET, NDC 59762-1810-02. Recall # D-099-2012;
 
99) PARoxetine, 30 MG, TABLET, a) NDC 00378-7003-93, b) NDC 59762-1812-01, c) NDC 65862-0156-30. Recall # D-100-2012;
 
100) PARoxetine, 40 MG, TABLET, a) NDC 00378-7004-93, b) NDC 59762-1815-01. Recall # D-101-2012;
 
101) PARoxetine HCl CR, 12.5 MG, TABLET, a) NDC 00029-3206-13, b) NDC 00378-2003-93, c) NDC 00378-2004-93. Recall # D-102-2012;
 
102) Pediatric Acetaminophen 120 MG, SUPPOSITORY, NDC 00713-0118-12. Recall # D-103-2012; 
 
103) Pediatric Glycerin SUPPOSITORY, 1.2 GM, NDC 00713-0102-26. Recall # D-104-2012;
 
104) Pediatric Glycerin SUPPOSITORY, NDC 49348-0158-05. Recall # D-105-2012;
 
105) Penicillin V Potassium, 250 MG, TABLET, a) NDC 00093-1172-01, b) NDC 00781-1205-01, c) NDC 67253-0200-10, d) NDC 67253-0201-10, e) 67253-0201-50. Recall # D-106-2012;
 
106) Penicillin V Potassium, 500 MG, TABLET, a) NDC 00093-1174-01, b) NDC 00093-1174-10, c) NDC 00781-1655-01, d) NDC 59762-1537-01, e) NDC 59762-1537-02. Recall # D-107-2012;
 
107) Pentosan Polysulfate Sodium, 100 MG, CAPSULE, NDC 50458-0098-01. Recall # D-108-2012;
 
108) Pentoxifylline ER, 400 MG, TABLET, a) NDC 00093-5116-01, b) NDC 00378-0357-01. Recall # D-109-2012;
 
109) Perphenazine, 16 MG, TABLET, a) NDC 00603-5093-21, b) NDC 00781-1049-01. Recall # D-110-2012;
 
110) Perphenazine, 2 MG, TABLET, a) NDC 00603-5090-21, b) NDC 00781-1046-01. Recall # D-111-2012;
 
111) Perphenazine, 4 MG, TABLET, a) NDC 00603-5091-28, b) NDC 00781-1047-01. Recall # D-112-2012;
 
112) Perphenazine, 8 MG, TABLET, a) NDC 00603-5092-21, b) NDC 00781-1048-01. Recall # D-113-2012;
 
113) Phenazopyridine HCl, 100 MG, TABLET, a) NDC 64376-0811-01, b) NDC 65162-0517-10. Recall # D-114-2012;
 
114) Phenazopyridine HCl, 200 MG, TABLET, a) NDC 64376-0812-01, b) NDC 65162-0520-10. Recall # D-115-2012;
 
115) Phenelzine Sulfate, 15 MG, TABLET, NDC 00071-0350-60. Recall # D-116-2012;
 
116) Phenobarbital, 60 MG, TABLET, NDC 64125-0902-01. Recall # D-117-2012;
 
117) Phenobarbital, 64.8 MG, TABLET, NDC 00603-5167-21. Recall # D-118-2012;
 
118) Phenobarbital, 97.2 MG, TABLET, NDC 00603-5168-21. Recall # D-119-2012;
 
119) Phenobarbital/Hyoscyamine/Atropine/Scopolomine Liquid in CUPS, a) NDC 66213-0423-04, b) NDC 66213-0423-16, c) NDC 68032-0395-16. Recall # D-120-2012;
 
120) Phenytoin, 125 MG/5 ML, ORAL SUSP in a CUP, NDC 51672-4069-01. Recall # D-121-2012;
 
121) Phenytoin Sodium EXTENDED, 100 MG, CAPSULE, a) NDC 51672-4111-01, b) NDC 51672-4111-03, c) NDC 65162-0212-50. Recall # D-122-2012;
 
122) Phenytoin Sodium EXTENDED, 30 MG, CAPSULE, NDC 00071-3740-66. Recall # D-123-2012;
 
123) Phosphorus, 250 MG, TABLET, a) NDC 00486-1125-01, b) NDC 64980-0104-01. Recall # D-124-2012;
 
124) Phytonadione, 5 MG, TABLET, NDC 25010-0405-15. Recall # D-125-2012;
 
125) Pilocarpine HCl, 5 MG, TABLET, a) NDC 00054-0056-25, b) NDC 62856-0705-10. Recall # D-126-2012;
 
126) Pimozide, 1 MG, TABLET, NDC 57844-0151-01. Recall # D-127-2012;
 
127) Pimozide, 2 MG, TABLET, NDC 57844-0187-01. Recall # D-128-2012;
 
128) Pindolol, 5 MG, TABLET, NDC 00378-0052-01. Recall # D-129-2012;
 
129) Pioglitazone HCl, 15 MG, TABLET, a) NDC 64764-0151-04, b) NDC 64764-0151-05, c) NDC 64764-0151-06. Recall # D-130-2012;
 
130) PIioglitazone HCl, 30 MG, TABLET, a) NDC 64764-0301-14, b) NDC 64764-0301-15. Recall # D-131-2012;
 
131) Pioglitazone HCl, 45 MG, TABLET, NDC 64764-0451-25. Recall # D-132-2012;
 
132) Piroxicam, 10 MG, CAPSULE, NDC 00093-0756-01. Recall # D-133-2012;
 
133) Piroxicam, 20 MG, CAPSULE, a) NDC 00093-0757-01, b) NDC 29033-0013-01. Recall # D-134-2012;
 
134) Plavix, 75 MG, TABLET, NDC 63653-1171-06. Recall # D-135-2012;
 
135) Poly Vitamin, CHEW TABLET, NDC 00536-4304-01. Recall # D-136-2012;
 
136) Poly Vitamin w/ Iron, CHEW TABLET, a) NDC 00536-7816-01, b) NDC 00904-0536-60. Recall # D-137-2012;
 
137) Poly-Vi-Sol, DROPS in a SYRINGE, a) NDC 00087-0402-03, b) NDC 50383-0625-50. Recall # D-138-2012;
 
138) Polyvitamin w/ Iron, 10 MG/ML, ORAL SOLUTION in a SYRINGE, a) NDC 00087-0405-01, b) NDC 50383-0632-50. Recall # D-139-2012
 
139) Potassium Acid Phosphate, 500 MG, TABLET, NDC 00486-1111-01. Recall # D-140-2012;
 
140) Potassium Chloride, 10MEQ (750 MG), CAPSULE, NDC 62037-0560-01. Recall # D-141-2012;
 
141) Potassium Chloride, 8 MEQ K, CAPSULE, NDC 64011-0010-04. Recall # D-142-2012;
 
142) Potassium Chloride ER, 600 MG (8 mEq), CAPSULE, NDC 62037-0559-01. Recall # D-143-2012;
 
143) Potassium Chloride ER, 750MG (10MEQ), CAPSULE, NDC 62037-0560-01. Recall # D-144-2012;
 
144) Potassium Chloride, ORAL SOLN in a SYRINGE, 40 mEq/30ML, NDC 00904-1007-16. Recall # D-145-2012;
 
145) Potassium Citrate/Sodium Citrate/Citric Acid, in a SYRINGE, NDC 00121-0677-16. Recall # D-146-2012;
 
146) Potassium Citrate, 1080 MG (10MEQ), TABLET, NDC 00245-0071-11. Recall # D-147-2012;
 
147) Potassium Citrate ER, 10 MEQ, tablets, NDC 00254-0071-11. Recall # D-148-2012;
 
148) Potassium Citrate ER, 5 MEQ, TABLET, NDC 00178-0600-01. Recall # D-149-2012;
 
149) Potassium Gluconate, 550 MG, TABLET, NDC 31604-0135-08. Recall # D-150-2012;
 
150) Pramipexole Di HCL, 0.5 MG, TABLET, a) NDC 00555-0613-14, b) NDC 00781-5250-92. Recall # D-151-2012;
 
151) Pramipexole Di HCl, 1.5 MG, TABLET, NDC 00555-0615-14. Recall # D-152-2012;
 
152) Pramipexole Dihydrochloride, 0.125 MG, TABLET, a) NDC 00555-0617-62, b) NDC 00597-0183-90, c) NDC 00781-5248-92. Recall # D-153-2012;
 
153) Pramipexole Dihydrochloride, 0.25 MG, TABLET, a) NDC 00555-0612-14, b) NDC 16714-0585-01. Recall # D-154-2012;
 
154) Pramipexole Dihydrochloride, 1 MG, TABLET, NDC 00555-0614-14. Recall # D-155-2012;
 
155) Pravastatin Sodium, 80 MG, TABLET, NDC 68180-0488-09. Recall # D-156-2012;
 
156) Pravastatin Sodium, 10 MG, TABLET, NDC 00093-0771-98. Recall # D-157-2012;
 
157) Pravastatin Sodium, 20 MG, TABLET, a) NDC 68084-0187-01, b) NDC 68180-0486-02, c) NDC 68462-0196-90. Recall # D-158-2012;
 
158) Pravastatin Sodium, 40 MG, TABLET, a) NDC 00903-7202-10, b) NDC 68462-0197-90. Recall # D-159-2012;
 
159) Prazosin HCl, 1 MG, CAPSULE, a) NDC 00093-4067-01, b) NDC 00378-1101-01. Recall # D-160-2012;
 
160) Prazosin HCl, 2 MG, CAPSULE, NDC 00093-4068-10. Recall # D-161-2012;
 
161) Prazosin Hydrochloride, 5 MG, CAPSULE, NDC 00093-4069-01. Recall # D-162-2012
 
162) PrednisoLONE, 15 MG/5 ML, LIQUID in CUPS and SYRINGES, a) NDC 00093-6118-87, b) NDC 00121-0759-08, c) NDC 50383-0042-24, d) NDC 50383-0042-48, e) NDC 59630-0710-08, f) NDC 60432-0212-08. Recall # D-163-2012;
 
163) Prednisolone Sodium Phosphate, ORAL SOLUTION in CUPS, 5 MG/5ML, NDC 50383-0040-04. Recall # D-164-2012;
 
164) Prednisone, 1 MG, TABLET, NDC 00054-4741-25. Recall# D-165-2012;
 
165) Prednisone, 20 MG, TABLET, a) NDC 00143-1477-01, b) NDC 00591-5443-01, c) NDC 00603-5339-32. Recall # D-166-2012;
 
166) PredniSONE, 5 MG/5 ML, LIQUID in a CUP, NDC 00054-3722-63. Recall # D-167-2012;
 
167) Pregabalin 25 MG CAPSULE, NDC 00071-1012-68. Recall # D-168-2012;
 
168) Pregabalin 75 MG CAPSULE, NDC 00071-1014-68. Recall # D-169-2012;
 
169) Prempro, 0.3 MG/1.8 MG, TABLET, NDC 00046-1105-11. Recall # D-170-2012;
 
170) Prenatabs RX, TABLET, NDC 60258-0193-09. Recall # D-171-2012;
 
171) Prenatal Low Iron Prenate Plus, TABLET, NDC 64376-0818-01. Recall # D-172-2012;
 
172) Prenatal Low Iron Vinate M, TABLET, NDC 51991-0155-01. Recall # D-173-2012;
 
173) Prenatal 19, TABLET, NDC 60258-0196-01. Recall # D-174-2012;
 
174) Prenatal Multivitamin/Mineral/Folic Acid, TABLET, a) NDC 00904-5313-60, b) NDC 13811-0514-10. Recall # D-175-2012;
 
175) Prenatal Multivitamin/Mineral, Tablets, NDC 13925-0103-01. Recall # D-176-2012;
 
176) Prenatal Plus, TABLET, a) NDC 65162-0668-10, b) NDC 65162-0668-50, Recall # D-177-2012;
 
177) Prenatal, TABLET, a) NDC 00094-5313-60, b) NDC 51645-0837-01, c) 59630-0416-90. Recall # D-178-2012;
 
178) Prenatal Vitamins Trinate, TABLET, NDC 60258-0192-01. Recall # D-179-2012;
 
179) Prenavite/Prenatal, TABLET, NDC 00536-4063-01. Recall # D-180-2012;
 
180) Preservision, Softgels, NDC 24208-0532-10. Recall # D-181-2012;
 
181) Prednisone, 20 MG, TABLET, NDC 63739-0209-10. Recall # D-182-2012;
 
182) Primaquine Phosphate, 26.3 MG, TABLET, NDC 00024-1596-01. Recall D-183-2012;
 
183) Primidone, 250 MG, TABLET, a) NDC 00115-1031-01, b) NDC 00143-1484-01, c) NDC 00527-1231-01, d) NDC 00603-5372-21, e) NDC 65162-0545-10. Recall # D-184-2012;
 
184) Primidone, 50 MG, TABLET, NDC 00527-1301-01. Recall # D-185-2012;
 
185) Probenecid, 500 MG, TABLET, NDC 00591-5347-01. Recall # D-186-2012;
 
186) Probiotic CAPSULE, a) NDC 49100-0363-74, b) NDC 64980-0147-03. Recall # D-187-2012;
 
187) Progesterone, 100 MG, CAPSULE, NDC 00032-1708-01. Recall # D-188-2012;
 
188) Progesterone, 200 MG, CAPSULE, NDC 00032-1711-01. Recall # D-189-2012;
 
189) Prograf, 0.5 MG, CAPSULE, NDC 00469-0607-73. Recall # D-190-2012;
 
190) Promethazine HCl, 25 MG, TABLET, a) NDC 00591-5307-01, b) NDC 00603-5438-21, c) NDC 00781-1830-01, d) NDC 10702-0003-10, e) NDC 57664-0108-88, f) 68382-0041-01. Recall # D-191-2012;
 
191) Promethazine HCl/ Dextromethorphan HBr ,12.5 MG/30 MG PER 10 ML CUPS, NDC 60432-0604-16. Recall # D-192-2012;
 
192) Promethazine HCl/ Dextromethorphan HBr , 6.25 MG/15 MG/5 ML CUPS, NDC 00603-1586-58. Recall # D-193-2012;
 
193) Promethazine Hydrochloride SYRUP, 6.25 MG/5 ML, LIQUID in CUPS, a) NDC 60432-0608-04, b) NDC 60432-0608-16. Recall # D-194-2012;
 
194) Promethazine Hydrochloride SYRUP in CUPS, 6.25MG, NDC 00603-1584-54. Recall # D-195-2012;
 
195) Propafenone HCI ER, 225 MG, CAPSULE, a) NDC 00173-0786-01, b) NDC 49884-0209-02. Recall # D-196-2012;
 
196) Propafenone HCl, 225 MG, TABLET, NDC 00591-0583-01. Recall # D-197-2012;
 
197) Propafenone HCl ER, 325 MG, CAPSULE, a) NDC 00173-0788-01, b) NDC 49884-0210-02. Recall # D-198-2012;
 
198) Propantheline Bromide, 15 MG, TABLET, NDC 00054-4721-25. Recall # D-199-2012;
 
199) Propoxyphene HCl, 65 MG, CAPSULE, NDC 00603-5110-21. Recall # D-200-2012;
 
200) Propranolol HCl, 10 MG, TABLET, a) NDC 00591-5554-01, b) NDC 23155-0110-01. Recall # D-201-2012;
 
201) Propranolol HCl, 20 MG, TABLET, NDC 00591-5555-01. Recall # D-202-2012;
 
202) Propranolol HCl, 80 MG, TABLET, a) NDC 16714-0025-04, b) 23155-0114-01, c) 50111-0471-01. Recall # D-203-2012;
 
203) Propranolol HCl ER, 120 MG, CAPSULE, a) NDC 00173-0791-02, b) NDC 00228-2780-11, c) NDC 43478-0902-88, d) NDC 49884-0329-01. Recall # D-204-2012;
 
204) Propranolol HCl ER, 160 MG, CAPSULE, a) NDC 00228-2781-11, b) 00378-6260-01. Recall # D-205-2012;
 
205) Propranolol HCl ER, 80 MG, CAPSULE, a) NDC 00173-0790-01, b) NDC 00173-0790-02, c) NDC 00378-6180-01. Recall # D-206-2012;
 
206) Propylthiouracil, 50 MG, TABLET, a) NDC 00143-1480-01, b) NDC 00143-1840-01, c) 00228-2348-10. Recall # D-207-2012;
 
207) Protriptyline HCl, 5 MG, TABLET, a) NDC 00054-0210-25, b) 51285-0595-02. Recall # D-208-2012;
 
208) Pseudoephedrine HCl, 30 MG, TABLET, a) NDC 00904-5053-24, b) NDC 00904-5053-59. Recall # D-209-2012;
 
209) Pseudoephedrine HCl, ORAL SOLUTION in a SYRINGE, 15 MG/5 ML, NDC 50580-0536-04. Recall # D-210-2012;
 
210) Pseudoephedrine Hydrochloride, 30 MG, TABLET, a) NDC 37205-0445-80, b) NDC 00536-4391-35. Recall # D-211-2012
 
211) Pseudoephedrine Hydrochloride, 30 MG/5 ML, 5 ML/CUP, NDC 00121-0421-04. Recall # D-212-2012;
 
212) Pseudoephedrine Hydrochloride, 60 MG, TABLET, NDC 00904-5125-59. Recall # D-213-2012;
 
213) Pyrazinamide, 500 MG, TABLET, a) NDC 61748-0012-06, b) NDC 67253-0660-10. Recall # D-214-2012;
 
214) Pyridostigmine Bromide, 180 MG, TABLET, NDC 00187-3013-30. Recall # D-215-2012;
 
215) Pyridostigmine Bromide, 60 MG, TABLET, a) NDC 00115-3511-01, b) NDC 00187-3010-30, c) NDC 64720-0128-10. Recall # D-216-2012;
 
216) Pyridoxine, 100 MG, TABLET, NDC 00904-0518-60. Recall # D-217-2012;
 
217) Pyridoxine, 25 MG, TABLET, NDC 00536-4406-01. Recall # D-218-2012;
 
218) Pyridoxine HCl, 25 MG, TABLET, NDC 37864-0908-01. D-219-2012;
 
219) Pyridoxine HCl, 50 MG, TABLET, a) NDC 00536-4408-01, b) NDC 00536-4408-10, c) NDC 00904-0520-60, d) NDC 10135-0139-01, e) 51645-0909-01. Recall # D-220-2012;
 
220) Pyrimethamine, 25 MG, TABLET, NDC 00173-0201-55, Recall # D-221-2012;
 
221) Pancrease MT 20, capsules, NDC 00045-0346-60. Recall # D-222-2012
CODE
1) Lot: 210346113, Exp 02/09/12, 04/19/12; 210397190, Exp 02/08/12, 05/05/12, 05/17/12; 210427945, Exp 05/05/12, 05/17/12; 210427946, Exp 05/05/12, 05/18/12;
 
2) Lot: a) TE99047, Exp 08/16/11; b) 198538, Exp 06/18/11;
 
3) Lot: 197146, Exp 06/30/11;
 
4) Lot: a) 1170P76025, Exp 10/15/11,10/20/11; 1170P77603, Exp 03/16/12; b) 315172, Exp 07/02/11; 316567, Exp 09/29/11, 11/05/11,12/02/11; 116149A, Exp 01/11/12; 116152A, Exp 01/25/12, 01/26/12; 34000693C, Exp 05/11/12; c) 315207, Exp 06/15/11; 315820, Exp 07/06/11, 08/11/11, 08/31/11, 09/14/11; 316570, Exp 09/14/11, 10/08/11, 11/05/11, 11/17/11; 316707, Exp 11/17/11; 317214, Exp 11/17/11, 12/10/11; 116149A, Exp 01/05/12, 01/26/12, 02/07/12, 03/07/12, 03/21/12; 34000694A, Exp 03/21/12;
 
5) Lot: a) 35311827, Exp 09/30/11; b) L2643, Exp 03/30/12;
 
6) Lot: a) 3013843, Exp 11/26/11; b) HJ30410, Exp 01/27/12; c) HE18110, Exp 07/28/11; HG29410, Exp 09/30/11; d) HD04310, Exp 06/07/11; HD19510, Exp 06/30/11; HF44810, Exp 09/02/11; HG28910, Exp 09/30/11; HH15210, Exp 11/05/11;
 
7) Lot: a) HD08010, Exp 12/01/11; b) HG10910, Exp 04/11/12; HG30510, Exp 05/05/12; c) 9ME1250, Exp 05/27/11;
 
8) Lot: 35310968A, Exp 08/31/11;
 
9) Lot: HA19611, Exp 05/17/12; HB21710, Exp 06/08/11; HG11710, Exp 12/20/11;
 
10) Lot: a) F0446 SUBLOT A, Exp 12/16/11; b) 22577901, Exp 08/17/11; 22671501, Exp 10/26/11; 22818801, Exp 04/13/12; c) C004892, Exp 03/02/12; C100024, Exp 04/26/12; C100172, Exp 04/28/12;
 
11) Lot: a) 22432301, Exp 08/17/11; 22435801, Exp 10/26/11; 22598601, Exp 03/09/12, 03/15/12; 22599101, Exp 05/04/12; 22610601, Exp 02/11/12; b) C004755, Exp 02/22/12, 03/01/12;
 
12) Lot: A195184, Exp 05/03/12;
 
13) Lot: A178985, Exp 05/03/12;
 
14) Lot: a) A189543, Exp 04/03/12,04/12/12, 05/01/12; b) A176738, Exp 04/10/12; A176739, Exp 04/10/12; A180944, Exp 05/04/12; A186699, Exp 04/13/12, 05/04/12; A186705, Exp 05/04/12, 05/19/12; A195167, Exp 05/04/12, 05/19/12;
 
15) Lot: 637093, Exp 01/11/12, 05/04/12; 637094, Exp 02/14/12; 637096, Exp 03/28/12, 05/04/12, 05/10/12; 637097, Exp 04/19/12, 05/04/12; BET74A, Exp 05/31/11; BET75A, Exp 05/31/11;
 
16) Lot: 733162, Exp 04/14/12; 733164, Exp 05/11/12;
 
17) Lot: 709212, Exp 02/10/12; 709213, Exp 11/19/11, 01/05/12;
18) Lot: 30211793A, Exp 01/11/12;
19) Lot: 329399, Exp 05/10/12;
 
20) Lot: 8LB87, Exp 06/15/11;
 
21) Lot: G011V, Exp 06/17/11;
 
22) Lot: 19452603, Exp 09/30/11; 22302902, Exp 09/24/11; 25306002, 02/11/12; 32415202, Exp 05/11/12;
 
23) Lot: a) 28107602, Exp 09/08/11,09/09/11; 31612502, Exp 01/11/12; 32106108, Exp 02/23/12; 32414402, Exp 03/03/12; 32820901, Exp 03/28/12,04/27/12; b) 86342, Exp 12/07/11, 01/04/12; 29956202, Exp 01/28/12; 86342A, Exp 02/07/12;
 
24) Lot: 287117, Exp 03/30/12;
 
25) Lot: a) 93425AF21, Exp 02/11/12; 94493AF21, Exp 02/23/12; 95532AF21, Exp 02/29/12; b) 93317, Exp 06/17/11, 06/18/11; 093317, Exp 09/30/11; 102149, Exp 08/06/11, 09/22/11; 102367, Exp 01/11/12; 103192, Exp 01/11/12; 103422, Exp 04/11/12;
 
26) Lot: a) H037W, Exp 05/17/12; b) F005V, Exp 11/05/11, 10/21/11, 11/11/11; G029W, Exp 03/20/12, 04/06/12, 04/17/12, 04/27/12; J029V, Exp 12/15/11, 02/10/12, 02/22/12; c) 33541602, Exp 05/15/12;
 
27) Lot: a) 32121602, Exp 05/17/12; b) 25429404, Exp 07/26/11, 08/06/11, 08/12/11, 08/18/11, 07/19/11; 27859102, Exp 06/30/11, 09/07/11, 09/10/11, 09/13/11, 09/20/11; 31250802, Exp 09/20/11; 31688505, Exp 10/18/11, 11/19/11, 01/28/12, 02/23/12; 31929202, Exp 10/18/11; 31929206, Exp 10/28/11; 32546804, Exp 04/25/12; 33541602, Exp 04/12/12, 04/25/12; c) 30215905, Exp 12/07/11; 31051108, Exp 02/23/12, 03/09/12, 03/15/12, 05/09/12; 310510-11, Exp 05/02/12;
 
28) Lot: 92371AF21, Exp 11/18/11;
 
29) Lot: a) 01151AF, Exp 05/02/12; 01236AF, Exp 03/28/12; 01239AF, Exp 04/18/12, 04/26/12; 01387AF, Exp 04/24/12; 319248M, Exp 02/09/12; 86796AF21, Exp 06/04/11; 86807AF21, Exp 06/14/11; 86812AF21, Exp 06/23/11; 86840AF21, Exp 07/14/11; 86850AF21, Exp 07/07/11; 87904AF21, Exp 06/29/11; 89111AF21, Exp 08/09/11; 90176AF21, Exp 08/25/11; 91238AF21, Exp 09/30/11; 91242AF21, Exp 10/07/11; 92316AF21, Exp 10/26/11; 92318AF21, Exp 11/03/11; 92333AF21, Exp 11/10/11; 92334AF21, Exp 11/18/11; 92336AF21, Exp 11/24/11, 12/10/11,12/21/11; 93408AF21, Exp 12/15/11, 12/17/11; 94462AF21, Exp 01/11/12; 94468AF21, Exp 02/02/12; 94521AF21, Exp 02/09/12; 95546AF21, Exp 02/22/12, 02/23/12; 95573AF21, Exp 03/09/12; 95578AF21, Exp 03/15/12; b) 2901813, Exp 11/11/11; 3015530, Exp 03/14/12; 25084502, Exp 06/17/11; 27882504, Exp 08/17/11, 09/15/11; 30155303, Exp 04/19/12; c) 31051108, Exp 05/19/12;
 
30) Lot: C064V, Exp 09/22/11, 12/16/11; J026V, Exp 01/14/12; J036V, Exp 09/22/11; K009W, Exp 03/28/12; L005W, Exp 05/17/12, M144U1, Exp 07/28/11;
 
31) Lot: 3017523, Exp 09/28/11;
 
32) Lot: 3021246, Exp 05/17/12;
 
33) Lot: a) 0FE1727, Exp 10/14/11; 0HE1675, Exp 11/17/11, 01/05/12; OFE1727, Exp 07/01/11, 08/17/11, 08/25/11, 09/14/11, 11/30/11; OHE1672, Exp 11/30/11; OJE1715, Exp 11/18/11; OME1626, Exp 02/08/12; b) 12246, Exp 10/25/11; 12283, Exp 12/02/11; 12437, Exp 01/18/12; c) 1AE1326, Exp 04/27/12; 1AE1504, Exp 02/23/12; 1CE1433, Exp 04/24/12, 05/11/12, 05/16/12; 1DE1007, Exp 05/03/12; ODE1525, Exp 05/27/11;
 
34) Lot: a) 0EE2594, Exp 07/14/11; OEE2101, Exp 08/17/11; OFE2216, Exp 08/23/11; OHE1844, Exp 11/18/11; b) 0ME1831, Exp 02/23/12; ODE1523, Exp 05/27/11;
 
35) Lot: a) 272743, Exp 10/25/11; 289479, Exp 11/17/11; 312317, Exp 01/11/12; 351650, Exp 03/21/12, 05/09/12; b) 0LE1133, Exp 03/06/12; c) OEE2051, Exp 08/30/11;
 
36) Lot: 633B01, Exp 08/03/11, 09/28/11, 11/19/11, 01/26/12;
 
37) Lot: a) 1005512, Exp 03/31/12; b) 248D01, Exp 09/23/11, 09/27/11, 11/04/11, 03/31/12; 249D01, Exp 12/08/11, 12/15/11, 01/03/12, 01/18/12, 01/25/12, 02/07/12, 02/15/12, 03/01/12; 303G91, Exp 07/31/11; 727L91, Exp 08/06/11; 876H01, Exp 05/16/12; 877H01, Exp 03/13/12, 04/04/12, 04/07/12, 04/13/12, 04/18/12, 05/18/12; 916J91, Exp 06/09/11, 06/30/11; c) 00000101, Exp 05/19/12; 24691701, Exp 11/11/11; 24692001, Exp 09/27/11; 25550801, Exp 10/11/11; 26085801, Exp 12/17/11, 01/07/12; 26085901, Exp 02/16/12; 26460601, Exp 11/12/11, 03/15/12; 26460701, Exp 05/05/12; 26473301, Exp 04/18/12, 05/12/12; 246919001, Exp 06/29/11
 
38) Lot: 878H01, Exp 05/16/12;
 
39) Lot: a) 1012T16, Exp 05/11/12; b) 3019516, Exp 12/08/11; 3022447, Exp 02/15/12;
 
40) Lot: a) 1011T27, Exp 4/10/2012; b) 1008T13, Exp 03/01/12;
 
41) Lot: 0006301, Exp 04/10/12;
 
42) Lot: 3019334, Exp 04/19/12;
 
43) Lot: a) 2001858, Exp 04/19/12; b) 2021727, Exp 12/17/11, 12/28/11, 02/21/12;
 
44) Lot: 443013, Exp 04/27/12; 444028, Exp 04/17/12; 444029, Exp 04/17/1;
 
45) Lot: 437772, Exp 03/28/12;
 
46) Lot: a) 441690, Exp 09/30/11; 442489, Exp 12/07/11, 12/17/11, 04/28/12; 443960, Exp 02/14/12; b) 202128, Exp 09/16/11; 203672, Exp 11/24/11; c) 3016632, Exp 06/08/11; 3020339, Exp 11/17/11; 3020340, Exp 11/19/11; 3023057, Exp 02/17/12; 3023603, Exp 05/04/12;
 
47) Lot: ME090456, Exp 11/18/11;
 
48) Lot: a) ME090950, Exp 11/30/11; b) F032W, Exp 05/04/12; K058V, Exp 07/21/11;
 
49) Lot: a) ME090812, Exp 08/13/11; ME100085, Exp 03/31/12; b) F031W, Exp 03/09/12; G009V, Exp 07/21/11; K057V, Exp 12/10/11;
 
 
50) Lot: 314040, Exp 09/24/11; 317385, Exp 11/10/11; 318076, Exp 04/14/12; 318078, Exp 04/14/12;
 
51) Lot: E009042, Exp 02/07/12;
 
52) Lot: 30212338A, Exp 10/22/11, 11/03/11; 30212339A, Exp 12/08/11; 30214179A, Exp 03/28/12;
 
53) Lot: 30211816A, Exp 10/20/11, 11/04/11; 30213760A, Exp 01/25/12, 02/15/12, 03/03/12, 03/07/12; 30214511A, Exp 03/16/12;
 
54) Lot: 263664M, Exp 06/16/11; 295814M, Exp 08/13/11; 301121A, Exp 12/14/11, 01/27/12;
 
55) Lot: a) 30213906, Exp 01/31/12; b) 284704M, Exp 06/29/11, 07/19/11, 08/17/11; 298359A, Exp 09/13/11; 309504A, Exp 11/22/11; 317728A, Exp 12/10/11; 333467A, Exp 02/23/12, 03/16/12; 348408M, Exp 04/11/12, 05/15/12;
 
56) Lot: 35313163A, Exp 10/20/11;
 
57) Lot: L094E10A, Exp 12/20/11;
 
58) Lot: a) 6635790, Exp 11/08/11; 6635970, Exp 12/08/11; 6636220, Exp 01/07/12; 6636390, Exp 03/16/12; 6636670, Exp 04/27/12; 6636820, Exp 05/10/12; b) 6636410, Exp 05/18/12; c) 6636730, Exp 04/13/12, 6636800, Exp 04/28/12;
 
59) Lot: A818110A, Exp 04/21/12, 05/03/12;
 
60)Lot: A739912A, Exp 08/26/11;
 
61)Lot: A813679A, Exp 03/27/12;
 
62) Lot: A6461943, Exp 11/18/11;
 
63) Lot: NWA1260, Exp 02/07/12;
 
64) Lot: NVA1007, Exp 07/06/11, 08/25/11; NVA1008, Exp 10/19/11, 11/02/11, 11/30/11, 12/21/11; NVA1009A, Exp 04/04/12; NVA1010, Exp 05/10/12;
 
65) Lot: 54750, Exp 04/18/12; C1A71869A, Exp 04/14/12;
 
66) Lot: 104362, Exp 05/10/12;
 
67) Lot: a) 72133, Exp 07/01/11; 72521, Exp 08/27/11, 09/30/11; 97451, 05/19/12; 69758B, Exp 05/28/11, 06/09/11; 86725D, Exp 07/14/11; 88849A, Exp 10/31/11, 11/11/11; 88849C, Exp 10/11/11, 10/28/11; 88849d, Exp 11/19/11, 11/30/11, 12/17/11, 12/21/11, 02/23/12; 88898B, Exp 10/26/11, 11/05/11; 88898E, Exp 10/21/11; 89184A, Exp 11/11/11; 89285D, Exp 11/11/11; 90625C, Exp 03/15/12; 90822C, Exp 04/11/12; 90823A, Exp 01/13/12, 01/25/12, 01/26/12, 01/28/12, 02/03/12, 02/04/12, 02/14/12, 02/23/12; 90823C, Exp 04/21/12; 91990B, Exp 03/16/12; 92237A, Exp 02/29/12; 92636A, Exp 03/07/12; 92636B, Exp 04/27/12, 04/28/12, 05/04/12, 05/05/12; 93728B, Exp 03/31/12, 04/06/12, 04/27/12, 05/12/12; 93728C, Exp 03/20/12, 03/21/12, 03/24/12; 94334A, Exp 05/16/12; A1087A, Exp 05/18/12; 72521, Exp 08/17/11; b) 102655, Exp 03/24/12; c) A1087A, Exp 05/18/12; d) 239764, Exp 03/31/12; 312094, Exp 05/12/12; e) 8705U, Exp 06/21/11, 06/30/11; f) 8583 NC, Exp 08/26/11; 8583NC, Exp 07/12/11, 07/28/11, 07/29/11, 07/30/11, 08/05/11, 08/13/11, 08/16/11, 08/20/11, 09/13/11, 10/18/11, 11/08/11, 11/29/11, 12/08/11, 12/20/11, 01/05/12, 01/25/12, 01/26/12, 02/18/12, 03/16/12, 04/28/12, 05/03/12; g) 375142-07, Exp 05/18/12; h) 8583NDC, Exp 04/28/12, 05/03/12; i) 4977900, Exp 07/21/11; j) 312094, Exp 12/14/11, 02/07/12; k) 1BA05, Exp 05/05/12; 1CB76, Exp 05/17/12; l) OBA28, Exp 09/09/11; m) 0GA80, Exp 12/13/11, 01/12/12; 0KA77, Exp 02/08/12, 03/30/12; OCB74, Exp 09/09/11; n) OBA27, Exp 08/05/11, 08/30/11; OBA28, Exp 08/05/11, 08/30/11; OCB74, Exp 10/19/11;
 
68) Lot: a) 0ZP0262, Exp 10/29/11; 0ZP0953, Exp 06/25/11; 0ZP4015, Exp 01/19/12; 0ZP4062, Exp 08/26/11; 0ZP4616, Exp 02/03/12, 02/09/12; 0ZP5320, Exp 02/14/12; 0ZP5536, Exp 07/23/11; 0ZP6714, Exp 10/08/11, 10/11/11; 0ZP9600, Exp 11/18/11; 1003413W, Exp 06/01/11; 1ZP0429, Exp 05/05/12, 05/17/12; 1ZP0633, Exp 05/11/12, 05/17/12; 1ZP5722, Exp 03/03/12, 03/06/12; 1ZP6605, Exp 03/13/12; 1ZP7786, Exp 03/21/12, 03/24/12, 03/28/12; 1ZP8228, Exp 03/28/12; 1ZP8520, Exp 04/10/12, 04/11/12, 04/27/12; 1ZP8971, Exp 04/13/12, 04/18/12; 1ZP9280, Exp 04/24/12, 04/26/12, 04/28/12; 1ZP9854, Exp 05/18/12; OPZ1406, Exp 12/08/11; OZP0262, Exp 10/29/11; OZP0270, Exp 11/11/11, 11/17/11; OZP1208, Exp 11/12/11; OZP1209, Exp 11/30/11; OZP1329, Exp 07/22/11; OZP1885, Exp 12/08/11; OZP3250, Exp 08/06/11; OZP3400, Exp 08/12/11, 08/18/11; OZP3712, Exp 01/11/12; OZP4012, Exp 12/20/11, 12/21/11, 12/27/11; OZP4013, Exp 01/03/12, 01/13/12; OZP4062, Exp 09/07/11; OZP4456, Exp 01/11/12, 01/26/12, 02/09/12; OZP5319, Exp 02/11/12, 02/15/12; OZP5538, Exp 08/20/11, 08/30/11; OZP5695, Exp 09/13/11; OZP6259, Exp 09/21/11; OZP6714, Exp 10/11/11; OZP7069, Exp 09/30/11; OZP7129, Exp 10/21/11; OZP8453, Exp 09/14/11; b) 0ZP1329, Exp 07/15/11;
 
69) Lot: 10210180, Exp 12/16/11; 1281 0160, Exp 12/16/11; 67217, Exp 02/08/12; 1024712, Exp 01/14/12; 1026157, Exp 02/25/12; 1027634, Exp 04/24/12; 1012000, Exp 03/14/12
 
70) Lot: a) 3022683, Exp 05/17/12; 3024287, Exp 05/17/12; b) 0001001, Exp 05/15/12:
 
71) Lot: a) 3022683, Exp 02/08/12, 02/09/12; 3024287, Exp 04/24/12; b) 001001, Exp 03/30/12, 05/09/12; 0939303, Exp 01/17/12, 02/03/12; '0918001, Exp 06/11/11; '0939301, Exp 10/20/11;
 
72) Lot: a) 3016911, Exp 05/28/11; b) 3018619, Exp 08/30/11; 3019439, Exp 09/13/11; 3019442, Exp 09/30/11; 3019443, Exp 10/14/11; 3019445, Exp 01/05/12, 02/02/12; 3019447, Exp 01/18/12; 3020082, Exp 10/31/11; 3020084, Exp 11/17/11; 3020085, Exp 12/02/11; 3021769, Exp 12/16/11; 3023324, Exp 01/18/12; 3023326, Exp 03/07/12; 3023331, Exp 02/22/12; 3023930, Exp 08/31/11; 3023935, Exp 03/21/12; 3023937, Exp 04/04/12; 3023941, Exp 04/19/12, 3025214, Exp 05/17/12; 3025215, Exp 05/02/12; c) 0015902, Exp 03/01/12;
 
73) Lot: a) Y04029, Exp 12/14/11; b) 67923A, Exp 11/23/11, 02/01/12;
 
74) Lot: 9L004, Exp 07/09/11;
 
75) Lot: a) y02036, Exp 03/01/12; b) 3023653, Exp 01/31/12; 3024902, Exp 03/08/12; 3024904, Exp 02/09/12; c) JKJ1699A, Exp 01/10/12, 04/27/12;
 
76) Lot: 197719, Exp 03/29/12; ME100369, Exp 11/04/11; ME100545, Exp 08/13/11;
 
77) Lot: a) 328148, Exp 08/24/11; b) JK2297A, Exp 09/30/11;
 
78) Lot: JKJ3496A, Exp 12/27/11; JKJ3959A, Exp 01/18/12; JKJ3960A, Exp 02/14/12;
 
79) Lot: a) H6228, Exp 12/27/11; H6232, Exp 12/23/11; H6260, Exp 01/31/12; b) 30212731A, Exp 12/09/11; H0138, Exp 12/10/11; H0160, Exp 12/27/11; H0163, Exp 02/09/12, 03/03/12; H0166, Exp 01/13/12;
 
80) Lot: 317831, Exp 04/19/12;
 
81) Lot: a) H0080261, Exp 12/06/11; b) 3016287, Exp 08/05/11; 3018134, Exp 12/10/11; 3023178, Exp 05/04/12;
 
82) Lot: H0070471, Exp 10/20/11;
 
83) Lot: a) 3020315, Exp 12/27/11; b) 0015001, Exp 03/14/12, 03/22/12; 0990901, Exp 11/24/11, 12/15/11; 0994002, Exp 01/03/12; 0994101, Exp 02/03/12; 1036701, Exp 04/11/12;
 
84) Lot: 0LG227, Exp 02/11/12, 02/28/12, 03/13/12; ODG694, Exp 06/30/11, 08/26/11, 09/03/11, 09/10/11, 09/13/11, 09/16/11; OJG044, Exp 11/11/11, 12/21/11, 01/03/12, 01/13/12;
 
85) Lot: OEG784, Exp 06/10/11;
 
86) Lot: 199732, Exp 01/20/12, 01/25/12;
 
87) Lot: a) 197138, Exp 09/24/11; 198102, Exp 08/03/11; 200045, Exp 12/17/11; b) I1009092, Exp 01/13/12;
 
88) Lot: 903001, Exp 11/30/11; 903101, Exp 11/30/11;
 
89) Lot: a) 45395, Exp 06/09/11, 07/21/11; 45396, Exp 07/22/11, 07/31/11; 45795, Exp 08/31/11; 45885, Exp 10/11/11; 45982, Exp 11/10/11, 11/24/11, 02/28/12, 02/28/12; 46085, Exp 03/13/12, 03/30/12, 04/19/12, 04/30/12, 04/30/12; b) 46083, Exp 02/09/12; 46141, Exp 04/30/12;
 
90) Lot: a) 45404, Exp 06/09/11, 07/21/11, 07/22/11; 45596, Exp 08/09/11; 45624, Exp 08/27/11; 45705, Exp 08/31/11, 09/16/11; 45792, Exp 09/23/11; 45793, Exp 10/13/11; 45995, Exp 02/09/12; 46049, Exp 02/29/12; 46139, Exp 01/19/12, 02/28/12; 46217, Exp 04/11/12; 46284, Exp 03/14/12, 03/24/12; 46362, Exp 03/29/12, 04/04/12, 04/11/12, 04/19/12, 04/24/12, 05/09/12, 05/15/12; b) 46140, Exp 02/28/12; 46289, Exp 05/11/12;
 
91) Lot: a) 45401, Exp 07/21/11; 45543, Exp 07/22/11; 46146, Exp 02/09/12; 46218, Exp 02/23/12; 46287, Exp 03/28/12; 46389, Exp 05/09/12; b) 46293, Exp 04/04/12;
 
92) Lot: 903301, Exp 11/30/11;
 
93) Lot: a) 097046, Exp 11/17/11; b) 95563, Exp 06/17/11; 95910, Exp 07/15/11; 096609, Exp 01/31/12; 097046, Exp 12/06/11; 100331, Exp 02/11/12; 100579, Exp 04/25/12; 100580, Exp 02/11/12; 100885, Exp 04/24/12;
 
94) Lot: a) 1049879, Exp 01/26/12, 03/10/12; 1049881, Exp 03/31/12; b) C005388, Exp 03/01/12, 03/07/12, 03/17/12, 04/04/12, 04/21/12;
 
95) Lot: a) E39994, Exp 02/04/12; b) E13182, Exp 05/15/12; E81897, Exp 11/12/11; F00063, Exp 03/29/12; c) P41222, Exp 10/14/11; P41224, Exp 12/31/11; P41270, Exp 09/03/11; P41273, Exp 08/03/11; P41278, Exp 12/13/11; P41285, Exp 01/18/12; P41316, Exp 03/28/12; d) 1052054, Exp 03/20/12, 03/29/12, 04/25/12; e) 1049971, Exp 01/26/12, 02/03/12, 02/07/12, 02/10/12; 1052059, Exp 02/16/12, 02/21/12; 1052060, Exp 03/02/12, 03/06/12; 1052061, Exp 04/13/12; 1052062, Exp 05/08/12; f) 0940701, Exp 02/02/12; 0940801, Exp 05/19/12; 9904911, Exp 12/31/11;
 
96) Lot: 821702E21, Exp 06/15/11; 834732E21, Exp 07/27/11; 879302E21, Exp 09/16/11; 891982E21, Exp 10/22/11, 11/03/11; 011842E, Exp 04/10/12, 05/11/12; 014202E, Exp 05/11/12;
 
97) Lot: a) 06Y028, Exp 07/30/11; 06Y032, Exp 09/17/11; b) 3015089, Exp 10/08/11; 3015090, Exp 10/14/11, 10/21/11, 11/19/11, 12/07/11; 3020304, Exp 12/22/11; 3020305, Exp 03/03/12, 03/13/12, 03/29/12; c) PE0110015-A, Exp 02/22/12; d) PE0110006-A, Exp 10/18/11; PE0110009-A, Exp 12/08/11, 12/10/11; PE0110010-A, Exp 12/20/11, 12/28/11, 01/25/12; PE0110015-A, Exp 02/03/12, 02/09/12, 02/22/12; PE0110016-A, Exp 02/28/12; PE0110017-A, Exp 04/07/12;
 
98) Lot: PE0209047-A, Exp 08/17/11, 09/13/11, 10/31/11; PE0209048-A, Exp 11/30/11;
 
99) Lot: a) 3016255, Exp 10/26/11; b) PE0310022-A, Exp 10/25/11, 11/22/11, 12/01/11, 12/08/11, 01/10/12, 01/14/12, 01/21/12, 02/09/12, 02/21/12; PE0310030-B, Exp 03/09/12, 03/16/12, 04/10/12, 04/11/12, 04/18/12, 04/30/12; PE310030-B, Exp 03/06/12; c) PE0310019-A, Exp 11/30/11;
 
100) Lot: a) 3015845, Exp 08/31/11; 3018160, Exp 01/10/12; 3018161, Exp 02/29/12; b) PE0410011-A, Exp 10/11/11; PE0410032-A, Exp 10/28/11, 12/16/11, 01/03/12; PE0410072-A, Exp 01/26/12, 02/08/12, 02/14/12, 04/11/12;
 
101) Lot: a) 29P06, Exp 01/05/12, 02/14/12; b) 3015959, Exp 08/06/11; 3018163, Exp 09/30/11; 3018164, Exp 11/18/11, 11/19/11; 3018165, Exp 12/13/11; 3026252, Exp 02/22/12; 3026254, Exp 05/09/12, 05/19/12; c) 2001810, Exp 09/30/11; 2001811, Exp 11/04/11; 3016203, Exp 08/06/11;
 
102) Lot: 011811002, Exp 03/28/12, 04/19/12, 04/27/12;
 
103) Lot: 10210021, Exp 09/24/11;
 
104) Lot: 0J168, Exp 03/06/12, 04/27/12, 05/09/12, 05/19/12;
 
105) Lot: a) (L)35415883A, Exp 08/09/11; 35413856A, Exp 08/05/11; 35415883A, Exp 10/19/11, 01/04/12; 3541588OB, Exp 08/05/11; 35416634B, Exp 12/21/11; b) AN2383, Exp 12/09/11; c) 8PT234, Exp 10/19/11; d) 9DD021, Exp 07/29/11, 08/17/11; e) 94502, Exp 11/30/11; 94603, Exp 08/26/11;
 
106) Lot: a) (L)35417511B, Exp 07/15/11, 07/28/11, 08/09/11; (L)35418062A, Exp 10/06/11; 35415456A, Exp 06/25/11; 35418779A, Exp 11/17/11, 11/19/11, 12/21/11; b) 35417066A, Exp 10/20/11; c) AN1496, Exp 11/10/11; AN2387, Exp 09/16/11; AR8253, Exp 11/24/11; AR8254, Exp 12/28/11; d) PE5010010-A, Exp 11/24/11; e) PE5010003-A, Exp 09/13/11; PE5010004-A, Exp 09/20/11; PE5010025A, Exp 12/21/11;
 
107) Lot: 0JG038, Exp 10/21/11; 0JG999, Exp 10/11/11; 0KG108, Exp 11/24/11; OEG742, Exp 06/30/11, 08/12/11; OHG957, Exp 09/07/11; OLG3038, Exp 03/16/12;
 
108) Lot: a) 1008T28, Exp 10/06/11, 12/08/11; 1010T17, Exp 03/20/12; 1010t19, Exp 04/19/12; 1011T03, Exp 05/19/12; b) 3019218, Exp 08/31/11; 3019220, Exp 09/30/11; 3019221, Exp 02/03/12;
 
109) Lot: a) C0720211A, Exp 03/07/12; C0910610A, Exp 10/22/11; C1270810A, Exp 12/30/11, 01/03/12, 01/10/12, 01/11/12, 01/17/12, 01/19/12; C1840211A, Exp 03/21/12, 04/06/12, 04/14/12; b) 189149, Exp 06/10/11, 06/16/11, 06/17/11, 06/18/11; 191107, Exp 06/24/11, 07/01/11, 07/08/11, 07/15/11, 07/20/11, 08/06/11, 08/16/11, 08/17/11; 191469, Exp 07/26/11, 08/06/11, 08/17/11, 08/26/11, 09/03/11, 09/10/11; 201101, Exp 10/07/11; 201102, Exp 09/20/11, 10/15/11; 201104, Exp 10/26/11, 10/28/11; 201105, Exp 11/12/11, 12/02/11, 12/07/11; 202811, Exp 11/22/11, 11/24/11, 12/02/11, 12/07/11; BH9974, Exp 03/10/12, 03/14/12, 04/18/12; BN5048, Exp 05/03/12, 05/09/12;
 
110) Lot: a) C0920510B, Exp 11/11/11; C0930510A, Exp 02/10/12; b) 201188, Exp 01/11/12, 02/03/12, 04/06/12; V10008, Exp 10/22/11;
 
111) Lot: a) C0890610A, Exp 02/16/12; b) 204184, Exp 02/03/12; 204185, Exp 02/03/12; 204266, Exp 02/29/12; BK5395, Exp 03/14/12;
 
112) Lot: a) C1160311A, Exp 03/28/12; b) BJ3051, Exp 03/10/12, 03/15/12; BJ3052, Exp 04/06/12;
 
113) Lot: a) 101712, Exp 04/24/12; b) 6810016, Exp 09/09/11; 6810024, Exp 11/22/11; 6810026, Exp 11/24/11;
 
114) Lot: a) 010008, Exp 02/02/12; b) 6820036, Exp 01/31/12;
 
115) Lot: 777702, Exp 12/02/11;
 
116) Lot: C01310, Exp 01/27/12;
 
117) Lot: C1230111C, Exp 03/10/12; C1240311C, Exp 04/12/12;
 
118) Lot: C1060910A, Exp 01/28/12, 01/31/12;
 
119) Lot: a) 09-007, Exp 07/27/11, 10/25/11, 11/30/11; '09-011, Exp 09/28/11; 10-002, Exp 02/07/12; 10-004, Exp 03/20/12; 10-006, Exp 02/07/12, 02/22/12, 03/22/12, 04/14/12; 10-007, Exp 03/10/12, 04/03/12, 04/10/12, 04/11/12, 04/14/12, 04/28/12, 05/04/12; b) 09-011, Exp 11/24/11; 10-003, Exp 01/06/12, 03/27/12, 04/11/12, 05/04/12; 10-004, Exp 03/14/12, 04/27/12; 11-001, Exp 04/17/12, 05/04/12, 05/17/12; 11-002, Exp 05/12/12; c) 4710, Exp 09/22/11; 11510, Exp 12/20/11; 18010, Exp 03/16/12;
 
120) Lot: 108099, Exp 04/04/12;
 
121) Lot: a) 107092, Exp 01/20/12; b) 106288, Exp 09/03/11; 106289, Exp 09/10/11; c) HE01810, Exp 07/19/11;
 
122) Lot: V100473, Exp 06/16/11, 06/17/11, 06/29/11; V100490, Exp 06/10/11; V100491, Exp 07/08/11; V100652, Exp 08/30/11, 09/13/11; V100653, Exp 09/16/11, 10/07/11; V100704, Exp 07/09/11, 01/31/12; V100791, Exp 07/28/11, 07/30/11, 08/11/11, 08/16/11; V100963, Exp 10/18/11; V100964, Exp 11/03/11; V100965, Exp 11/19/11; V101523, Exp 12/21/11, 12/27/11; V101711, Exp 03/06/12;
 
123) Lot: a) 327334, Exp 03/28/12; 327335, Exp 02/03/12; 329147, Exp 03/22/12, 03/28/12; 329149, Exp 05/05/12, 05/15/12; b) 93319, Exp 06/09/11, 07/08/11; 93320, Exp 07/15/11, 07/16/11; 94065, Exp 09/08/11, 09/23/11, 10/11/11; 94066, Exp 08/25/11, 08/27/11; 101164, Exp 10/13/11, 10/21/11, 10/25/11, 11/09/11, 02/08/12; 101268, Exp 11/24/11, 11/30/11, 12/15/11, 02/08/12; 102414, Exp 12/21/11, 12/30/11, 01/04/12, 01/21/12, 01/25/12, 01/28/12, 02/08/12, 04/13/12; 102537, Exp 02/04/12, 02/07/12, 02/14/12, 02/15/12, 02/24/12, 03/01/12, 03/09/12; 102538, Exp 05/12/12; 106711, Exp 04/19/12; 107511, Exp 04/11/12, 04/19/12, 107611, Exp 04/19/12; 110811, Exp 05/19/12; '093319, Exp 06/29/11; '093320, Exp 08/04/11; '094065, Exp 09/16/11, 09/28/11, 10/25/11;
 
124) Lot: 41152, Exp 07/26/11; 0B163, Exp 06/09/11; 0B164, Exp 07/08/11, 07/28/11, 08/03/11, 08/06/11, 09/30/11; 0E510, Exp 09/15/11, 10/06/11, 12/21/11; 0F641, Exp 10/29/11, 04/13/12; 0L262, Exp 02/03/12, 05/18/12; 0L263, Exp 03/09/12, 03/31/12, 04/06/12, 05/01/12, 05/09/12, 05/11/12, 05/18/12; OB164, Exp 06/21/11; OF641, Exp 11/19/11, 11/30/11, 12/21/11, 12/30/11, 01/11/12, 02/14/12, 02/17/12, 04/06/12;
 
125) Lot: a) 061194A, Exp 03/10/12; b) CHNG, Exp 02/08/12; CHNH, Exp 05/11/12;
 
126) Lot: 30210166A, Exp 11/30/11;
 
127) Lot: 30211810A, Exp 11/11/11, 11/12/11; 30213159A, Exp 12/08/11, 01/11/12;
 
128) Lot: 3W0064, Exp 11/17/11, 11/19/11;
 
129) Lot: a) C16567, Exp 07/30/11; A16262, Exp 06/03/11; A16352, Exp 08/04/11; A16783, Exp 11/05/11, 11/08/11; A16789, Exp 11/17/11; A16949, Exp 12/23/11, 01/05/12; A16950, Exp 12/07/11; A17127, Exp 03/08/12; A17245, Exp 05/03/12; A17286, Exp 03/21/12; A17287, Exp 11/05/11, 04/14/12, 04/18/12; A17289, Exp 03/29/12; C16768, Exp 11/30/11; C17009, Exp 02/16/12; C17012, Exp 03/17/12; C17105, Exp 03/28/12; C17197, Exp 04/19/12; C17199, Exp 05/19/12; b) A16264, Exp 06/03/11, 07/01/11; A16509, Exp 07/08/11, 07/14/11; A16511, Exp 08/06/11; A16607, Exp 09/07/11, 09/20/11; A16789, Exp 11/19/11; A16869, Exp 11/12/11; A16952, Exp 12/09/11, 12/17/11, 12/21/11, 01/07/12; a17044, Exp 01/27/12; A17131, Exp 02/11/12; A17244, Exp 03/09/12, 03/10/12, 04/18/12; A17273, Exp 04/18/12; C16300, Exp 06/16/11, 06/24/11, 07/14/11; C16303, Exp 06/03/11; C16373, Exp 08/20/11, 08/27/11; C16677, Exp 11/17/11, 11/19/11; C16765, Exp 10/11/11, 10/15/11, 01/07/12; C17194, Exp 02/29/12, 03/03/12; C17198, Exp 03/28/12; C17207, Exp 04/12/12, 04/27/12; C17397, Exp 04/11/12, 04/13/12, 05/02/12; C17428, Exp 04/25/12, 04/26/12, 05/01/12, 05/02/12, 05/12/12; c) A16951, Exp 12/07/11;
 
130) Lot: a) A16356, Exp 06/16/11, 06/21/11; A16420, Exp 06/03/11, 06/04/11, 6/10/11, 07/30/11; A16421, Exp 07/27/11; A16519, Exp 07/01/11; A16611, Exp 08/11/11, 08/16/11; A16612, Exp 08/04/11, 09/15/11; A16794, Exp 11/03/11; A16796, Exp 10/21/11; A16876, Exp 11/03/11; A16957, Exp 11/11/11; A16961, Exp 12/07/11; A16962, Exp 01/11/12; A16964, Exp 12/27/11, 12/30/11; A17049, Exp 01/28/12; A17050, Exp 01/12/12, 01/25/12; A17134, Exp 02/22/12, 03/01/12; A17260, Exp 04/04/12; A17283, Exp 03/29/12; A17299, Exp 05/03/12; A17445, Exp 05/18/12; C16498, Exp 07/08/11, 07/19/11; C16680, Exp 01/06/12; C16773, Exp 11/19/11; C16930, Exp 02/10/12; C17018, Exp 03/14/12; C17203, Exp 03/31/12; C17295, Exp 05/09/12, 05/17/12, 05/19/12; C16379, Exp 06/17/11; b) A16266, Exp 06/03/11; A16518, Exp 07/01/11; A16699, Exp 09/07/11; A16792, Exp 10/11/11, 10/15/11; A16957, Exp 11/19/11; a17046, Exp 12/21/11; A17070, Exp 01/26/12; A17071, Exp 02/21/12; A17141, Exp 02/09/12; A17256, Exp 04/12/12; A17274, Exp 03/30/12; C16679, Exp 09/30/11; C16682, Exp 08/06/11, 08/20/11; C17110, Exp 01/07/12; C17202, Exp 03/09/12, 03/13/12; C17298, Exp 05/03/12;
 
131) Lot: A16520, Exp 07/28/11; A16615, Exp 08/27/11; A16802, Exp 10/11/11; A16803, Exp 10/26/11, 12/10/11; A17061, Exp 01/07/12; A17261, Exp 03/09/12; A17293, Exp 03/13/12; A17459, Exp 05/05/12; C16384, Exp 07/26/11; C16389, Exp 07/01/11; C17023, Exp 01/07/12, 01/12/12;
 
132) Lot: 26Y004, Exp 12/28/11, 05/17/12; 26Y006, Exp 02/11/12; 26Y010, Exp 06/14/11;
 
133) Lot: a) 27Y013, Exp 07/28/11; 27Y033, Exp 11/01/11; 27Y036, Exp 12/15/11; b) PIR200301, Exp 11/03/11;
 
134) Lot: OF57078, Exp 08/03/11;
 
135) Lot: 0541 0150, Exp 04/19/12; 0551 1120, Exp 04/19/12; 0761 0140, Exp 04/19/12; 1651 9050, Exp 10/31/11;
 
136) Lot: a) 0621 9011, Exp 06/18/11, 08/12/11; 0741 0160, Exp 11/17/11; 1161 0111, Exp 04/14/12, 05/17/12; 1161 0140, Exp 09/16/11, 10/19/11, 12/21/11; 1761 0180, Exp 02/03/12, 03/13/12; b) 102350, Exp 11/18/11;
 
137) Lot: a) 115482A, Exp 06/01/11; b) 606023, Exp 03/01/12;
 
138) Lot: a) 117571A, Exp 06/08/11; 118071A, Exp 07/13/11; 118341A, Exp 08/20/11, 09/25/11; 119752A, Exp 11/09/11, 12/07/11; 119754A, Exp 01/13/12; 120679A, Exp 03/07/12, 04/11/12; 121375A, Exp 05/04/12; 121835A, Exp 05/04/12; b) 606935, Exp 03/24/12; 608382, Exp 03/24/12, 04/11/12;
 
139) Lot: 237328, Exp 03/28/12; 329146, Exp 03/28/12, 04/13/12; 329150, Exp 05/12/12;
 
140) Lot: 304951M, Exp 11/05/11; 283963M, Exp 08/03/11; 339324M, Exp 01/04/12, 01/18/12; 340764M, Exp 01/13/12; 352090M, Exp 02/03/12; 352751M, Exp 02/04/12; 375589M, Exp 03/27/12, 04/11/12;
 
141) Lot: 200340V, Exp 09/30/11;
 
142) Lot: 303840a, Exp 02/02/12; 355716A, Exp 02/02/12;
 
143) Lot: 377198M, Exp 05/19/12;
 
144) Lot: 0H03, Exp 05/19/12;
 
145) Lot: 9K20, Exp 07/09/11;
 
146) Lot: 0H020, Exp 01/11/12; 0K012, Exp 02/23/12; 0M015, Exp 04/11/12;
 
147) Lot: 0, Exp 06/14/11;
 
148) Lot: 0J043, Exp 04/25/12;
 
149) Lot: 1022443, Exp 04/24/12;
 
150) Lot: a) 314462, Exp 06/24/11; 315884, Exp 10/22/11; 315885, Exp 08/06/11; 316230, Exp 12/17/11; 317107, Exp 02/03/12; 317110, Exp 01/04/12; b) KW10G095, Exp 12/09/11; KW10G099, Exp 05/01/12;
 
151) Lot: 316368, Exp 05/17/12; 317695, Exp 05/17/12;
 
152) Lot: a) 314467, Exp 01/11/12; 317218, Exp 05/03/12; 702782, Exp 06/03/11; 33800308A, Exp 05/19/12; b) 061135A, Exp 02/09/12; c) KW10F031, Exp 05/17/12;
 
153) Lot: a) 315215, Exp 10/22/11; 316335, Exp 11/30/11; 316382, Exp 03/28/12; 03/30/12, 04/19/12, 05/01/12, 05/19/12; 316986, Exp 02/23/12, 02/29/12; b) G00270A, Exp 03/02/12;
 
154) Lot: 40999, Exp 08/10/11; 315214, Exp 10/29/11, 11/24/11, 01/11/12;
 
155) Lot: 3102885, Exp 11/16/11, 02/09/12;
 
156) Lot: 03Y054, Exp 01/18/12;
 
157) Lot: a) 102351, Exp 07/28/11; b) 3105499, Exp 05/04/12; c) 2100068, Exp 07/27/11;
 
158) Lot: a) 33Y021, Exp 06/07/11; 33Y034, Exp 07/28/11; 33Y071, Exp 09/02/11; 33Y122, Exp 11/05/11; b) 02100675, Exp 11/30/11, 02/07/12;
 
159) Lot: a) 30211117A, Exp 06/25/11; b) 3017527, Exp 12/07/11; 3018628, Exp 01/26/12, 02/09/12;
 
160) Lot: 30211084A, Exp 06/01/11;
 
161) Lot: 30211648A, Exp 07/21/11;
 
162) Lot: a) 30210474A, Exp 10/14/11; b) 607849, Exp 01/13/12; c) 0D70, Exp 10/31/11; 0D71, Exp 10/20/11, 10/31/11; 0F06, Exp 12/10/11, 12/16/11; 0F62, Exp 12/31/11; 0J03, Exp 03/10/12; 0J05, Exp 03/03/12; 0M76, Exp 03/08/12; 1A66, Exp 03/28/12, 04/24/12, 05/05/12; 1B65, Exp 04/11/12; 1B81, Exp 04/28/12, 04/28/12; 1C30, Exp 05/17/12; OC10, Exp 06/17/11; OC54, Exp 09/01/11; OC81, Exp 09/16/11; OD65, Exp 10/08/11; d) 607648, Exp 12/17/11, 12/30/11; 608741, Exp 05/17/12; 603774, Exp 11/30/11; 605059, Exp 08/18/11; 606916, Exp 11/19/11; 607569, Exp 02/01/12; 607849, Exp 12/29/11, 02/01/12; 607909, Exp 01/27/12; 607983, Exp 02/11/12; 608253, Exp 02/17/12, 03/31/12; 608373, Exp 03/31/12; 608548, Exp 03/16/12, 03/31/12; 609283, Exp 05/17/12; e) RS0802B, Exp 07/13/11; RS1001D, Exp 05/04/12; f) 30311A, Exp 07/09/11, 07/22/11; 30367A, Exp 10/31/11; 30674A, Exp 03/09/12, 03/13/12; 30711A, Exp 04/17/12;
 
163) Lot: 604701, Exp 05/27/11; 604857, Exp 05/27/11; 609121, Exp 05/02/12;
 
164) Lot: 064045A, Exp 03/21/12;
 
165) Lot: a) 67455B, Exp 06/10/11; 68381B, Exp 01/28/12, 02/22/12; b) 333009M, Exp 02/09/12; c) C10507108, Exp 02/08/12;
 
166) Lot: 060312A, Exp 09/15/11;
 
167) Lot: V091995, Exp 09/09/11; V100275, Exp 09/14/11, 09/29/11; V100489, Exp 08/09/11; V100862, Exp 09/29/11, 10/18/11; V101754, Exp 03/03/12; V110015, Exp 03/31/12, 04/06/12, 04/11/12, 04/13/12; V110304, Exp 04/25/12, 04/26/12, 05/09/12;
 
168) Lot: V101374, Exp 12/30/11;
 
169) Lot: E67958, Exp 10/06/11;
 
170) Lot: 101121, Exp 06/23/11; 101316, Exp 06/23/11, 07/30/11, 08/27/11; 101441, Exp 09/23/11; 101442, Exp 09/13/11; 101650, Exp 09/23/11, 10/15/11, 10/21/11; 101651, Exp 10/21/11, 04/13/12; 102581, Exp 04/27/12; 102582, Exp 12/21/11; 103129, Exp 01/05/12, 01/18/12; 103130, Exp 01/18/12, 02/07/12, 04/13/12; 104407, Exp 02/29/12, 03/01/12, 03/14/12; 104589, Exp 03/28/12, 04/06/12, 04/11/12, 05/02/12, 05/10/12;
 
171) Lot: 103261, Exp 04/17/12;
 
172) Lot: 103141, Exp 05/01/12;
 
173) Lot: 103131, Exp 02/09/12, 03/10/12;
 
174) Lot: a) 101684, Exp 11/23/11, 12/08/11, 12/29/11, 12/30/11, 01/26/12, 01/27/12, 02/03/12; 101685, Exp 09/02/11; 102392, Exp 03/24/12; 102394, Exp 02/29/12, 03/02/12; 103274, Exp 03/24/12, 04/11/12, 04/21/12, 04/27/12, 04/28/12; 103387, Exp 03/23/12, 03/27/12, 03/28/12, 03/31/12, 05/08/12; 104038, Exp 02/24/12, 02/29/12, 03/15/12; 104039, Exp 04/21/12; b) 42132113, Exp 06/07/11; 42330302, Exp 11/05/11; 42554506, Exp 08/03/11; 41005129, Exp 05/18/12;
 
175) Lot: 41012121, Exp 04/18/12, 05/02/12;
 
176) Lot: a) 32565, Exp 04/11/12; 32704, Exp 02/24/12; 33490, Exp 11/12/11; 33544, Exp 12/15/11; 33845, Exp 03/07/12; 33995, Exp 03/31/12; 408539A, Exp 05/09/12; 408544A, Exp 05/19/12; b) 31972, Exp 06/09/11; 32448, Exp 08/06/11; 32942, Exp 11/17/11; 33438, Exp 11/17/11; 33541, Exp 12/27/11;
 
177) Lot: a) 101685, Exp 08/27/11; b) 33139, Exp 02/23/12; 33506, Exp 03/29/12; 33866, Exp 03/29/12, 03/31/12, 05/19/12; c) F37511, Exp 05/31/11; F38585, Exp 07/31/11; F42377, Exp 12/17/11; F42765, Exp 12/08/11, 12/17/11, 01/13/12; F43104, Exp 03/13/12, 03/31/12;
 
178) Lot: 94249, Exp 06/15/11, 08/11/11; 101439, Exp 09/22/11, 10/26/11, 01/14/12; 102475, Exp 11/30/11, 12/21/11, 01/14/12, 04/04/12, 04/18/12, 05/05/12; 104381, Exp 04/04/12, 04/18/12, 05/05/12; '094249, Exp 09/22/11;
 
179) Lot: 1531 0170, Exp 04/24/12;
 
180) Lot: 5791KK713, Exp 04/04/12;
 
181) Lot: 69185, Exp 05/31/11;
 
182) Lot: 204440B, Exp 01/04/12; 204820B, Exp 07/14/11;
 
183) Lot: a) 10000342, Exp 05/05/12; b) 65860B, Exp 10/31/11; 68224A, Exp 05/05/12; c) 2010489322, Exp 04/18/12; 2010529479, Exp 05/19/12; d) T135B10A, Exp 07/21/11; e) 5450005A, Exp 12/21/11, 02/14/12, 02/21/12, 03/29/12
 
184) Lot: 2010107089, Exp 08/31/11; 2010197635, Exp 12/08/11; 2010429073, Exp 03/08/12; 2010489314, Exp 03/30/12;
 
185) Lot: 288046M, Exp 05/28/11; 291166M, Exp 10/08/11; 291167A, Exp 11/26/11, 12/13/11, 12/15/11, 01/25/12, 02/10/12; 298356M, Exp 07/13/11; 336126M, Exp 04/12/12, 05/02/12;
 
186) Lot: a) 09L0303, Exp 06/09/11; 10209C162, Exp 10/11/11; 10209C1GA, Exp 10/21/11, 10/28/11, 11/05/11, 11/24/11, 12/14/11; 10285C1G2, Exp 12/06/11, 12/22/11, 12/30/11, 01/10/12, 01/13/12; 10323C1G2, Exp 01/19/12, 01/25/12, 01/26/12, 02/11/12, 02/16/12, 03/01/12, 03/03/12, 03/07/12, 03/15/12, 03/23/12, 03/29/12, 03/30/12, 04/12/12, 04/18/12; 10C0074, Exp 08/25/11; 11003C1G2, Exp 04/27/12, 05/01/12, 05/04/12, 05/09/12, 05/15/12, 05/17/12, 05/19/12; b) 7835-10, Exp 06/03/11; 7835-13, Exp 12/31/11; 7835-15, Exp 03/09/12; 7835-17, Exp 03/09/12, 03/20/12; 7835-9, Exp 06/03/11;
 
187) Lot: 500585, Exp 07/13/11; 500686, Exp 02/22/12; Exp 09/28/11;
 
188) Lot: 500698, Exp 02/29/12;
 
189) Lot: a) 276231A, Exp 01/20/12, 02/15/12, 02/28/12; 298360A, Exp 11/12/11; 309534A, Exp 03/29/12, 03/31/12; 365344M, Exp 05/12/12, 05/15/12; b) T011G10A, Exp 01/12/12; T176E10A, Exp 10/19/11; c) 192683, Exp 05/27/11; 197455, Exp 11/24/11; 204587, Exp 02/11/12; d) 10343, Exp 06/07/11; 10451, Exp 07/28/11, 09/02/11; 10452, Exp 09/30/11; e) BVJ0021A, Exp 01/31/12; f) MK1983, Exp 07/30/11; MK8165, Exp 04/07/12; MK8168, Exp 05/08/12;
 
190) Lot: 30235A, Exp 08/18/11, 09/22/11, 11/24/11; 30504a, Exp 01/28/12, 02/11/12; 30713A, Exp 03/13/12; Lot: 30235A, Exp 08/18/11, 09/22/11, 11/24/11; 30504a, Exp 01/28/12, 02/11/12; 30713A, Exp 03/13/12;
 
191) Lot: 30235A, Exp 08/18/11, 09/22/11, 11/24/11; 30504a, Exp 01/28/12, 02/11/12; 30713A, Exp 03/13/12;
 
192) Lot: L023M10A, Exp 04/11/12;
 
193) Lot: a) 300301A, Exp 09/15/11; b) 30102A, Exp 09/15/11; 30594A, Exp 04/17/12;
 
194) Lot: L045F10A, Exp 10/26/11;
 
195) Lot: a) 0ZP7687, Exp 12/28/11; b) 22441407, Exp 03/10/12;
 
196) Lot: 44588A, Exp 10/29/11;
 
197) Lot: a) OZP1395, Exp 03/10/12; b) 22441604, Exp 03/14/12;
 
198) Lot: 958935A, Exp 06/16/11, 06/18/11, 08/26/11, 08/31/11, 09/30/11;
 
199) Lot: T152F10A, Exp 11/19/11;
 
200) Lot: a) 333470A, Exp 05/10/12; b) BSG0011AC, Exp 01/04/12, 02/09/12; BSG0015AC, Exp 03/28/12;
 
201) Lot: 257534M, Exp 06/25/11;
 
202) Lot: a) 73546, Exp 04/26/12; b) BSK0003AC, Exp 10/13/11, 11/02/11; BSK0005AC, Exp 12/10/11, 01/21/12; BSK0006AC, Exp 01/21/12, 02/02/12; BSK1001AC, Exp 04/07/12; BSK1002AC, Exp 05/03/12, 05/10/12; BSK9010AC, Exp 06/29/11, 09/23/11, 09/29/11; BSK9014AC, Exp 06/23/11, 06/29/11, 07/15/11, 08/17/11, 09/13/11; BSK9016AC, Exp 08/11/11, 08/13/11; BSK9017AC, Exp 08/30/11, 09/07/11; c) 315152, Exp 03/14/12;
 
203) Lot: a) 985305, Exp 02/02/12; b) 678H01, Exp 10/08/11; 811L01, Exp 03/14/12; c) D63554, Exp 09/30/11; E50913, Exp 03/14/12, 04/28/12; E58903, Exp 11/03/11, 11/17/11, 11/30/11; E78417, Exp 12/21/11; d) 22582401, Exp 12/30/11;
 
204) Lot: a) 287G01, Exp 11/03/11; 743H01, Exp 11/17/11; 855L01, Exp 02/08/12; b) 2001881, Exp 01/31/12;
 
205) Lot: a) 1022164, Exp 01/11/12, 01/28/12, 02/22/12; b) 1022168, Exp 01/05/12, 02/09/12, 03/31/12, 05/03/12; c) 3017679, Exp 11/30/11; 3024276, Exp 04/18/12;
 
206) Lot: a) 67326A, Exp 09/03/11, 10/25/11; 67512A, Exp 01/10/12, 01/27/12, 02/24/12; b) 67327A, Exp 05/03/12; c) 184A11, Exp 04/04/12; 186A11, Exp 04/04/12;
 
207) Lot: a) 958188A, Exp 06/17/11; b) 310422, Exp 06/15/11; 703717, Exp 04/13/12;
 
208) Lot: a) OLE1528, Exp 01/28/12; b) P59389, Exp 06/18/11; P61255, Exp 08/26/11; P61985, Exp 10/28/11; P66672, Exp 03/01/12, 03/06/12; P67322, Exp 04/26/12; P67464, Exp 05/05/12;
 
209) Lot: 05480B, Exp 02/02/12;
 
210) Lot: a) 0HE1521, Exp 11/11/11; b) C062W, Exp 10/28/11
 
211) Lot: 0J82, Exp 02/03/12;
 
212) Lot: P54117, Exp 06/18/11; P61475, Exp 08/25/11, 08/26/11; P62946, Exp 11/11/11; P63464, Exp 11/19/11, 12/01/11, 12/28/11; P63914, Exp 01/26/12, 02/04/12, 02/16/12; P65668, Exp 03/06/12, 04/04/12; P65669, Exp 03/09/12; P67329, Exp 04/25/12;
 
213) Lot: a) F090273B, Exp 06/08/11; b) 68618A, Exp 04/19/12;
 
214) Lot: 0J2234, Exp 04/27/12, 05/04/12;
 
215) Lot: a) H0060181, Exp 10/08/11, 02/23/12; b) 0D1493, Exp 05/04/12; 0D2111, Exp 05/04/12; c) 105695, Exp 01/11/12; 105956, Exp 02/14/12;
 
216) Lot: 32391, Exp 11/05/11; 32812, Exp 12/06/11, 01/04/12, 02/03/12, 02/21/12, 02/22/12; 33718, Exp 03/15/12, 04/27/12;
 
217) Lot: 31655, Exp 06/18/11;
 
218) Lot: 33028, Exp 12/08/11;
 
219) Lot#: a) 31654, Exp 07/09/11, 07/16/11; 32082, Exp 06/16/11, 06/29/11, 07/28/11, 08/03/11, 08/12/11, 08/13/11; 32083, Exp 08/30/11, 09/10/11; 32824, Exp 10/07/11, 10/22/11, 11/11/11, 11/19/11; 33074, Exp 11/19/11, 12/07/11; 33075, Exp 12/28/11, 02/11/12; 33457, Exp 02/11/12; 33459, Exp 03/14/12, 03/15/12, 05/18/12; 33855, Exp 05/10/12; 34062, Exp 05/01/12, 05/17/12; b) 04610150, Exp 11/17/11, 12/10/11, 01/14/12; 11110120, Exp 08/17/11; 0461 0150, Exp 10/21/11, 09/14/11; 1111 0120, Exp 07/15/11; c) 32397, Exp 10/14/11; 32412, Exp 09/14/11, 10/14/11, 03/07/12; 33075, Exp 10/14/11, 11/30/11; 33724, Exp 12/28/11, 01/20/12; 34111, Exp 03/02/12, 03/17/12, 03/28/12, 03/30/12, 04/17/12, 04/19/12; 34622, Exp 05/01/12, 05/02/12, 05/16/12; 26707215, Exp 08/06/11; 28185216, Exp 08/23/11, 09/09/11; d) 3101, Exp 07/31/11; e) 33457, Exp 03/10/12; 34294, Exp 04/10/12, 04/27/12;
 
220) Lot: A44519, Exp 03/14/12;
 
221) Lot: 0EG759, Exp 06/02/11
RECALLING FIRM/MANUFACTURER
Aidapak Services, LLC, Vancouver, WA,by letters on May 27, 2011, May 28, 2011 and May 31, 2011, and by press release on June 1, 2011. FDA initiated recall is ongoing.
REASON
Penicillin Cross Contamination: There is potential for beta-lactam cross contamination of non-penicillin drug products repackaged in the same facility.
VOLUME OF PRODUCT IN COMMERCE
679,333 tablets, capsules, softgels, lozenges, pieces, suppositories, syringes, and cups
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Pediatric Atropine Sulfate Injection, USP, 0.05 mg/mL; Single Dose, NDC 0409-9630-05, Recall # D-677-2012
CODE
Lot 82-397-EV
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letter on August 5, 2011.
Manufacturer: Hospira, Inc., Rocky Mount, NC. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products; OOS result for total impurities at the 8 month stability testing interval.
VOLUME OF PRODUCT IN COMMERCE
37,100 syringes
DISTRIBUTION
Nationwide, Puerto Rico and Guam
___________________________________
PRODUCT
1) Piperacillin and Tazobactam for Injection, 2.25 grams, ADD-Vantage Vial For IV Use, Rx Only, NDC 0409-3374-02. Recall # D-678-2012;
 
2) Piperacillin and Tazobactam for Injection, 3.375 grams, ADD-Vantage Vial For IV Use, Rx Only, NDC 0409-3378-13. Recall # D-679-2012;
 
3) Piperacillin and Tazobactam for injection, 4.5 grams, ADD-Vantage Vial For IV Use, Rx Only, NDC 0409-3379-04. Recall # D-680-2012
CODE
1) Lot #: 010018M, Exp 10/12; 950028M, 950038M, Exp 11/12; 010198M, Exp 02/13; 040108M, Exp 04/13;
 
2) Lot #: 020308M, Exp 02/11; 030108M, 030118M, Exp 03/11; 040138M, Exp 04/11; 950088M, Exp 11/12; 010048M, 010068M, 010078M, Exp 01/13;
 
3) Lot #: 950098M, 950108M, Exp 11/12; 010098M, Exp 01/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz Inc., Princeton, NJ, by letter on September 29, 2011.
Manufacturer: Sandoz GmbH, Kundl, Austria. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter: Product had out-of-specification results for particulate counts.
VOLUME OF PRODUCT IN COMMERCE
588,100 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Docetaxel injection 80 mg/2 mL, For Intravenous Infusion Only After Final Dilution, Rx only, 1 Vial Each Docetaxel Injection and Diluent per kit, NDC 16729-228-50. Recall # D-805-2012;
 
2) Docetaxel injection 20 mg/0.5 mL, For Intravenous Infusion Only After Final Dilution, Rx only, 1 Vial Each Docetaxel Injection and Diluent per kit, NDC 16729-120-49. Recall # D-806-2012
CODE
1) Lot #s: M05572, M05577, M05643, Exp 05/12; M07098, Exp 06/12;
 
2) Lot # s: M07099, M05578 M05644, M05574, Exp 05/12; M07202, Exp 06/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Accord Healthcare Inc., Durham, NC, by letter on/about September 26, 2011.
Manufacturer: INTAS Pharmaceuticals Limited, Matoda, Ahmedabad, Gujarat, India. Firm initiated recall is ongoing.
REASON
Labeling: Correct Labeled Product Miscart/Mispack; The product is packaged in kits with a packaging configuration of one Docetaxel vial and one Diluent vial. Some kits were found to contain two vials of Docetaxel Injection or two vials of Diluent for Docetaxel Injection instead of the intended packaging configuration of one Docetaxel vial and one Diluent vial.
VOLUME OF PRODUCT IN COMMERCE
55,135 Kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Fludeoxyglucose F18 Injection in a vial, Diagnostic - For Intravenous Administration, Rx only, Each ml contains 10-200 mCi of no carrier added 2-deoxy-2 [18F] fluoro-D-glucose at EOS in an isotonic solution. 18F half life = 110 minutes. Calculate dosage from date and time calibration. Recall # D-850-2012
CODE
Lot #: FDGNY111103101, Exp 10/31/11 at 1315; FDGNY111103102, Exp 10/31/11 at 1515; FDGNY111103103, Exp 10/31/11 at 1715
RECALLING FIRM/MANUFACTURER
Recalling Firm: IBA Molecular North America Inc., Dulles, VA, by telephone, fax or e-mail on October 31, 2011.
Manufacture: IBA Molecular North America Inc., Colonie, NY. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: The firm decided to recall the product as a precautionary measure when a possible mold issue was observed in environmental monitoring samples and visually on wall surfaces behind a wall cabinet in the plant.
VOLUME OF PRODUCT IN COMMERCE
61 doses
DISTRIBUTION
NY, PA
___________________________________
PRODUCT
Cetirizine Hydrochloride Tablets, 10mg, 100 count bottles, (NDC 116571-402-10). Recall # D-852-2012
CODE
PUZ1005, PUZ1006 expiry date June 2014 and PUZ1007 expiry date July 2014
RECALLING FIRM/MANUFACTURER
Unique Pharmaceutical Labs (Div. of J.B. Chemicals & Pharm.), Panoli, India, by letters on October 19, 2011. Firm initiated recall is ongoing.
REASON
Labeling; Label Error on Declared Strength; outer label indicates strength as 10mg however inner label indicates strength as 5mg.
VOLUME OF PRODUCT IN COMMERCE
55,344 bottles (at 100 tablets per bottle)
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Migergot (Ergotamine Tartrate and Caffeine Suppositories USP), Each Rectal Suppository contains: Ergotamine Tartrate USP 2 mg, Caffeine USP 100 mg, Tartaric Acid 21.5 mg, 12 Rectal Suppositories per Box, Rx Only, NDC 0713-0166-12. Recall # D-711-2012
CODE
Lot #: 016609002, Exp 07/12
RECALLING FIRM/MANUFACTURER
G & W Laboratories Inc., South Plainfield, NJ, by letters on June 20, 2011. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Product was out of specification for a known degradation product, ergotaminine.
VOLUME OF PRODUCT IN COMMERCE
10,968 Boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Ropinirole Hydrochloride Tablets, 0.25 mg, 100-count tablets per bottle, Rx only, NDC 64720-201-10. Recall # D-807-2012;
 
2) Ropinirole Hydrochloride Tablets, 0.5 mg, 100-count tablets per bottle, Rx only, NDC 64720-202-10. Recall # D-808-2012;
 
3) Ropinirole Hydrochloride Tablets, 1 mg, 100-count tablets per bottle, Rx only, NDC 64720-203-10. Recall # D-809-2012;
 
4) Ropinirole Hydrochloride Tablets, 2 mg, 100-count tablets per bottle, Rx Only, NDC 64720-204-10. Recall # D-810-2012
CODE
1) Lot #: 102232, Exp 03/11; 102794, 102795, Exp 05/11; 103611, 103612, Exp 07/11; 104441, Exp 10/11; 104876, Exp 01/12; 105557, 105558, Exp 03/12;
 
2) Lot #: 100364, Exp 03/11; 101184, Exp 05/11; 101310, 101311, Exp 06/11; 101649, Exp 07/11; 101865, Exp 08/11; 102239, Exp 09/11; 102793, Exp 11/11; 103537, Exp 01/12; 103989, Exp 03/12; 105027, Exp 06/12; 105202, Exp 07/12; 105559, 105560, Exp 09/12;
 
3) Lot #: 100849, 100897, Exp 04/11; 101182, 101183, Exp 05/11; 101341, Exp 06/11; 101787, Exp 07/11; 102119, 102120, Exp 09/11; 102458, 102459, Exp 10/11; 102961, 102962, Exp 12/11; 103668, 104442, Exp 04/12; 104878, 104879, Exp 07/12; 105514, 105515, Exp 09/12;
 
4) Lot #: 100838, Exp 04/11; 101280, Exp 06/11; 101650, Exp 07/11; 101922, 101923, Exp 08/11; 102796, Exp 11/11; 103613, Exp 01/12; 104067, Exp 04/12; 104623, Exp 05/12; 105518, 105519, Exp 09/12
RECALLING FIRM/MANUFACTURER
Corepharma LLC, Middlesex, NJ, by letters dated April 1, 2011. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Ropinirole Hydrochloride Tablets may not meet the specification for a known impurity over the product shelf life.
VOLUME OF PRODUCT IN COMMERCE
1,103,813 bottles
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
delos (benzoyl peroxide) cleanser, 3.5%, 6 oz (180 g) tube, Rx only, NDC 49908-123-80.
Recall # D-838-2012
CODE
Lot #: 4300, Exp 12/12
RECALLING FIRM/MANUFACTURER
IGI Inc., Buena, NJ, sent a recall letter on July 18, 2011. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient) Drug: Low assay results for benzoyl peroxide was found during stability testing.
VOLUME OF PRODUCT IN COMMERCE
12,924 tubes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Femtrace (estradiol acetate) tablets, 1.8 mg, 100-count tablets per bottle, Rx only, NDC 0430-0391-24, UPC N3 0430-0391-24 1. Recall # D-851-2012
CODE
Lot 01940, Exp. 05/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Warner Chilcott Inc., Rockaway, NJ, by letters on June 21, 2011 on November 4, 2011. 
Manufacturer: Warner Chilcott Company LLC, Fajardo, PR. Firm initiated recall is ongoing. 
REASON
Failed USP Dissolution Test Requirements: The recalled lot failed dissolution at the 9-month timepoint.
VOLUME OF PRODUCT IN COMMERCE
2,535 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Source Plasma. Recall # B-0079-12
CODE
Units: 5290053517, 5290052980, 5290052688, 5290052478, 5290052214, 5290051903, 5290051645, 5290051327, 5290048512, 5290048110, 5290047880, 5290047521, 5290047188, 5290046857, 5290046480, 5290046061, 5290045644, 5290045315, 5290044857
RECALLING FIRM/MANUFACTURER
Octapharman Plasma, Inc., Greenville, MI, by electronic mail on May 16, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was illiterate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-0089-12;
2) Fresh Frozen Plasma. Recall # B-0090-12
CODE
1) and 2) Unit: LM65633
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on September 1, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis LeukocytesReduced, Recall # B-0091-12
CODE
Unit: FN18867
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on March 23, 2007 and April 17, 2007. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0105-12
CODE
Unit: LH51821
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on January 18, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0109-12;
CODE
Unit: W038611814095
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by electronic mail on August 24, 2011 and September 2, 2011. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PR
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0155-12
CODE
Units: 7545410 (Bags 1 and 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, inc-cellular Therapy Laboratory, New York, NY, by telephone on September 29, 2007 and by letter dated October 2, 2007.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Source Plasma. Recall # B-0177-12
CODE
Units: 12 GCGFFR, 12 GCGFFB, 4120633071, 4120632673, 4120630717, 4120629858, 4120627735, 4120626817, 4120624739, 4120623082, 4120620783, 4120620173, 4120618047, 4120616745, 4120614874, 4120613883, 4120611844, 4120610890, 4120609090, 4120607872, 4120202205, 4120201276, 4120199929, 4120198974, 4120196270, 4120194624, 4120193788, 4120191433, 4120189704, 4120188771, 4120186098, 4120185540, 4120184326, 4120183206, 4120181849, 4120180848, 4120179708, 4120177538, 4120176635, 4120174952, 4120174090, 4120172431, 4120171688, 4120170225, 4120169517, 4120168019, 4120167103, 4120165376, 4120164506, 4120162763, 4120161976, 4120160263, 4120159643, 4120157610, 4120157151, 4120155465, 4120154547, 4120153146, 4120152398, 4120150655, 4120149980, 4120147970, 4120147499, 4120145595, 4120145103, 4120143336, 4120142377, 4120140884, 4120140459, 4120138669, 4120137884, 4120136321, 4120135726, 4120134057, 4120133455, 4120131499, 4120130877, 4120129719, 4120128712, 4120127262, 4120126613, 4120125094, 4120124639, 4120080105, 4120079405, 4120078436, 4120076985, 4120064230, 4120063192, 4120062722, 4120061650, 4120061089, 4120059791, 4120059432, 4120058074, 4120057884, 4120056470, 4120056082, 4120054994, 4120054517, 12 GCFYBY, 12 GCFXXF, 12 GCFXWM, 12 GCFXSP, 12 GCFXRS, 12 GCGDYX, 12 GCGDXV, 12 GCGDVJ, 12 GCGDTB, 12 GCGDPW, 12 GCGDMX, 12 GCGDKR, 12 GCFVQC, 12 CLYLCB, 12 CLYKGM, 12 CLYJRK, 12 CLYHQR, 12 CLYHHW, 12 CLYGNC, 12 CLYGCQ, 12 CLXTKV, 12 CLXSTQ, 12 CLXSFC, 12 CLXRPN, 12 CLVZXR, 12 CLVZBL, 12 CLVYSQ, 12 CLVYCX, 12 CLVXSQ, 12 CLVWYT, 12 CLVWTH, 12 CLVTZF, 12 CLVTPS, 12 CLVSTD, 12 CLSBPV, 12 CLSBGK, 12 CLRZRK, 12 CLRZDZ, 12 CLRYPR, 12 CLRYGN, 12 CLRWWN, 12 CLRWTL
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Indianapolis, IN, by facsimile and electronic mail on February 10, 2010 and February 23, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from donors who were previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
142 units
DISTRIBUTION
IL, Switzerland, and Germany
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0186-12
CODE
Unit: W041011049074A
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc dba United Blood Services, Scottsdale, AZ, by telephone and facsimile on August 5, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled RBC antigen negative tested RBC antigen positive, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
___________________________________
PRODUCT
Source Plasma. Recall # B-0187-12
CODE
Units: FD0648335; FD0649301
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Farmington, NM, by facsimile on June 29, 2011 and electronic mail on September 19, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UK
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0188-12
CODE
Unit: LR61437
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Mather, CA, by facsimile on September 8, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0189-12
CODE
Units: W035808116543 (2 units)
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Mather, CA, by facsimile on September 17, 2008. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Irradiated. Recall # B-0190-12
CODE
Unit: 7071691
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, inc-cellular Therapy Laboratory, New York, NY,  by telephone on May 1, 2007.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood product, for which the irradiation may not have been performed correctly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0191-12
CODE
Units: 8318792, W224308303271
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by telephone and facsimile on September 25, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0193-12
CODE
Units: 3780095452, 3780094977, 3780094694, 3780094219, 3780093934, 3780091442, 3780090835, 3780087275, 3780084393, 3780083672, 3780083508, 3780081869, 3780081630, 3780081144, 3780080995, 3780080011, 3780079880, 3780079415, 3780079028, 3780078816, 3780078076, 3780077664, 3780077145, 3780076840, 3780076333, 3780076089, 3780075636, 3780075312, 3780074358, 3780073961, 3780073448, 3780073159, 3780072628, 3780072193, 3780071168, 3780070840, 3780070244, 3780069992, 3780068962, 3780068632, 3780067796, 3780067470, 3780066813, 3780066285, 3780065882, 3780065422, 3780064776, 3780064026, 3780063684, 3780063012, 3780062746, 3780062063, 3780061766, 3780061034, 3780060658, 3780059875, 3780059439, 3780058708, 3780058349, 3780057311, 3780057127, 3780056304, 3780055312, 3780055055, 3780054318, 3780054104, 3780053482, 3780053130, 3780052497, 3780052213, 3780051532, 3780051236, 3780050631, 3780050153, 3780049396, 3780048724, 3780048330, 3780047804, 3780047515, 3780046989, 3780046334, 3780045915, 3780045533, 3780044706, 3780043953, 3780042888, 3780042332, 3780042083, 3780041147, 3780039297, 3780038223, 3780037156, 3780036663, 3780036466, 3780035784, 3780034352, 3780033914, 3780033492, 3780033052, 3780032465, 3780032185, 3780031020, 3780030878, 3780030476, 3780029840, 3780029309, 3780027624, 3780027327, 3780026094, 3780025535, 3780024538, 3780024170, 3780021455, 3780020511, 3780020171, 3780017584, 3780016424, 3780012794, 3780011845, 3780011418, 3780010527, 3780009944, 3780009373, 3780008265, 3780006725, 3780004906, 3780004158
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Baton Rouge, LA, by facsimile on September 8, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who could not read English, were distributed.
VOLUME OF PRODUCT IN COMMERCE
127 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-0194-12
CODE
Units: 3780094536, 3780093798, 3780093513, 3780092221, 3780089940, 3780089616, 3780089215, 3780088263, 3780088050, 3780087589, 3780087348, 3780086844, 3780086458, 3780086099, 3780085695, 3780085302, 3780084976, 3780084474, 3780084266, 3780083653, 3780083391, 3780082907, 3780082710, 3780082263, 3780082049, 3780081620, 3780081389, 3780080956, 3780080689, 3780080317, 3780080059, 3780079736, 3780079486, 3780078348, 3780077888, 3780077529, 3780076968, 3780076736, 3780076220, 3780075393, 3780075238, 3780074456, 3780073992, 3780003932, 3780003316, 3780002857, 3780002266, 3780001756, 3780001413, 3780000961
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Baton Rouge, LA, by facsimile on July 23, 2010. Firm initiated recall is complete. 
REASON
Blood products, collected from a donor who could not read English, were distributed.
VOLUME OF PRODUCT IN COMMERCE
50 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-0195-12
CODE
Units: 3780092122, 3780090445, 3780087662, 3780086986, 3780086742, 3780086212, 3780085929, 3780085437, 3780084664, 3780080651, 3780080475, 3780079892, 3780078834, 3780078620, 3780078023, 3780077775, 3780077221, 3780076962, 3780076429, 3780076153, 3780075709, 3780075423, 3780074566, 3780073813, 3780073231, 3780072978, 3780072221, 3780072030, 3780071384, 3780070923, 3780070562, 3780070075, 3780069500, 3780069102, 3780068470, 3780067932, 3780067508, 3780066886, 3780066470, 3780050729, 3780049985, 3780049058, 3780048131, 3780047235, 3780046898, 3780045512, 3780044558, 3780044205, 3780042668, 3780042258, 3780041747, 3780041451, 3780040913, 3780040587, 3780040056, 3780039767, 3780039267, 3780038986, 3780038530, 3780038277, 3780037858, 3780037610, 3780037241, 3780036733, 3780036532, 3780035968, 3780035631, 3780035158, 3780034854, 3780034298, 3780033780, 3780032958, 3780032637, 3780032127, 3780031809, 3780031410, 3780031161, 3780030825, 3780030532, 3780029943, 3780029642, 3780029076, 3780028756, 3780028175, 3780027751, 3780027059, 3780026698, 3780025981, 3780025702
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Baton Rouge, LA, by facsimile on July 12, 2010. Firm initiated recall is complete. 
REASON
Blood products, collected from a donor who could not read, were distributed.
VOLUME OF PRODUCT IN COMMERCE
89 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-0210-12
CODE
 Units: 4600071863, 4600071187, 4600070044, 4600069790
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Salt Lake City, UT,  by facsimile on August 23, 2010. Firm initiated recall is complete
REASON
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0212-12
CODE
Unit: W158010106663
RECALLING FIRM/MANUFACTURER
Arup Laboratories, Inc., Sandy, UT, by letter dated September 19, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
UT
___________________________________
PRODUCT
1) Plasma. Recall # B-0213-12;
2) Red Blood Cells. Recall # B-0214-12;
3) Platelets. Recall # B-0215-12
CODE
1) Unit: W038511332401;
2) Units: W038511332401, 5010270;
3) Unit: 5010270 
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on October 11, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
FL, GA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0241-12
CODE
Recall # W158311600206
RECALLING FIRM/MANUFACTURER
Blood Bank of the Washington Hospital Center-Union Memorial, Baltimore, MD, by telephone on September 16, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD, D.C.
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0242-12;
2) Platelets Pooled Leukocytes Reduced. Recall # B-0243-12;
3) Recovered Plasma. Recall # B-0244-12
CODE
1) Unit: 6750622;
2) Unit: 1011583;
3) Unit: 6750622
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by facsimile on September 19, 2011 and letter on October 12, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria, OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0245-12
CODE
Units: W038111093673; W038110363864
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on September 11, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0246-12
CODE
Unit: 55FW09869
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by facsimile on September 20, 2011. Firm initiated recall is complete.
REASON
Donor Deferral/Donor missing or incorrectly identified on deferral list, donor was or should have been previously deferred due to testing was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AR
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0247-12
CODE
Units: W044610366831; W044610482899; W044611218747; W044610310213
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by fax on July 6, 2011, July 8, 2011 and July 12, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Bone: Patella Wedge Lyo, 7 mm. Recall # B-0249-12
CODE
Units: 030486171, 030486172
RECALLING FIRM/MANUFACTURER
DCI Donor Services Tissue Services Division, Nashville, TN, by letter on October 6, 2011 and followed by a telephone call on October 10, 2011 and October 11, 2011. Firm initiated recall is complete.
REASON
Bone allografts, with positive post-processing swab cultures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0251-12
CODE
Unit: LS19534
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Chico, CA, by telephone on April 30, 2008 and May 1, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, Switzerland
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0255-12
Code
Units: W069111136490 (Part 1); W069111136490 (Part 2)
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc, Jackson, MS by telephone on September 6, 2011 and facsimile on September 21, 2011. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications for release, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0026-12
CODE
Units: W067309014001 (part 1); W067309014001 (part 2); W067310004666; W067310012791 (part 1); W067310012791 (part 2); W067310018231 (part 1); W067310018231 (part 2); W067310020901
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Amarillo, TX, by letter on September 7, 2011. Firm initiated recall is complete.
REASON
Blood products, prepared without the appropriate amount of storage solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 products
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0174-12
CODE
Units: 041GQ49846; 026FJ76543
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by facsimile on July 22, 2011 and August 22, 2011. Firm initiated recall is complete,
REASON
Blood products, labeled as negative for red cell antibodies but tested positive for red cell antibodies, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0175-12
CODE
Units: LQ16000; LQ18337; LQ15613; GG16571; GF85749
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on February 16, 2007. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable storage temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pooled Leukocytes Reduced. Recall # B-0185-12
CODE
Unit: W088411403017
RECALLING FIRM/MANUFACTURER
Blood Bank Of Hawaii, Honolulu, HI, by letter on August 19, 2011. Firm initiated recall is complete.
REASON
Blood product, collected without documenting the donor's body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
HI
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0209-12
CODE
Units: W035808004887, W035808004883
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Mather, CA, by facsimile on November 7, 2008. Firm initiated recall is complete. 
REASON
Blood products, which may have reached an unacceptable temperature during manufacturing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0211-12
CODE
Unit: W036811235061
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Lauderhill, FL, by letter dated September 20, 2011. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an incorrect volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Influenza Virus Vaccine. Recall # B-0248-12
CODE
Units: U3599AA, U3600AA, U3603AA, U3604BA, U3606AA, U3609AA, U3611AA
RECALLING FIRM/MANUFACTURER
Sanofi Pasteur, Inc., Swiftwater, PA, by letter dated September 1, 2010. Firm initiated recall is complete.
REASON
Fluzone High Dose vaccine, with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 lots
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0250-12
CODE
Unit: LS19534
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Chico, CA, by telephone on April 30, 2008 and May 1, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, Switzerland
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I
___________________________________
PRODUCT
Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL ARM, 201251 RIO GUIDANCE MODULE, 200294 RIO CAMERA STAND ASSEMBLY***PN 203999 SN ROB 125 2010-12 V 100/120/230 A 9.6/8.0/4.2 Hz 50/60 Class I Equipment. Conforms to IEC 60601-1/A2: 1995, EN 60601-1/A2: 1995 UL 60601-1: 2003, CAN/CSA-C22.2 No. 601.1-M90. RIO System - The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Tactile Guidance System v2.0 is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be approriate, and where reference to rigid anatomical bony structures can be identified relative to a CT base model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement. Recall Z-0146-2012
CODE
Lot numbers: ROB034, ROB035, ROB036, ROB037, ROB038, ROB042, ROB044, ROB045, ROB046, ROB047, ROB048, ROB049, ROB050, ROB051, ROB053, ROB054, ROB055, ROB056, ROB057, ROB059, ROB060, ROB061, ROB062, ROB062, ROB063, ROB066, ROB067, ROB069, ROB070, ROB071, ROB072, ROB073, ROB074, ROB075, ROB076, ROB077, ROB078, ROB079, ROB080, ROB081, ROB082, ROB083, ROB084, ROB085, ROB086, ROB088, ROB093, ROB094, ROB096, ROB097, ROB098, ROB099, ROB100, ROB101, ROB102, ROB103, ROB104, ROB107, ROB108, ROB109, ROB110, ROB112, ROB114, ROB116, ROB117, ROB118, ROB120, ROB121, ROB122, ROB123, ROB124
RECALLING FIRM/MANUFACTURER
Mako Surgical Corp., Davie, FL, by letter dated February 1, 2011, Firm initiated recall is ongoing.
REASON
Software issue that exist that could potentially result in a bone resection. No adverse events reported
VOLUME OF PRODUCT IN COMMERCE
68 units
DISTRIBUTION
Nationwide and Scotland, Italy and Korea
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges. Recall # Z-0069-2012
CODE
Lot Numbers ED2098, EA2111, FB2134, ED2147
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter on August 31, 2011. Firm initiated recall is ongoing.
REASON
Firm has confirmed customer complaints for low recovery of QC and patient samples.
VOLUME OF PRODUCT IN COMMERCE
6,072 cartons
DISTRIBUTION
Puerto Rico, Guam, Austria, Canada, Croatia, France, Greece, Germany, Italy, Japan, Mexico, Portugal, Spain and Switzerland
___________________________________
PRODUCT
Bard Ventralex" ST Medium Circle with Strap Hernia Patch Diameter 6.4cm /2.5", Catalog Number: 5950008. Intended for use in the reconstruction of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair hernias and deficiencies caused by trocars. Recall Z-0144-2012
CODE
Lot number: HUVD1253
RECALLING FIRM/MANUFACTURER
Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Warwick, RI, by letter on October 4, 2011.
Manufacturer: Bard Shannon LTD, Humacao, PR. Firm initiated recall is complete.
REASON
Mislabeled: Bard Ventralex" ST Medium Circle was packaged in a pre-printed carton identified for a Bard Ventralex" ST Large Circle.
VOLUME OF PRODUCT IN COMMERCE
96 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY. Part Number 8071M4K1 distributed in Canada Part Number 8071M5 distributed in Europe/Middle East/Africa Part Number 8071M9 distributed in Hong Kong, Korea, Malaysia. Recall # Z-0145-2012
CODE
Item Lot # 8071M0H1 1018162 8071M0H1 1018863 8071M0H1 1019314 8071M0H1 1023474 8071M0H1 1023492 8071M0H1 1023887 8071M0H1 1024580 8071M0H1 1025106 8071M0K1 1017325 8071M0K1 1017326 8071M0K1 1017327 8071M0K1 1017328 8071M0K1 1017329 8071M0K1 1017570 8071M0K1 1017571 8071M0K1 1017572 8071M0K1 1017573 8071M0K1 1017580 8071M0K1 1017581 8071M0K1 1017582 8071M0K1 1017583 8071M0K1 1017584 8071M0K1 1017659 8071M0K1 1017660 8071M0K1 1017661 8071M0K1 1017662 8071M0K1 1017663 8071M0K1 1017664 8071M0K1 1017665 8071M0K1 1017666 8071M0K1 1017667 8071M0K1 1017668 8071M0K1 1017669 8071M0K1 1017670 8071M0K1 1017671 8071M0K1 1017672 8071M0K1 1017673 8071M0K1 1017674 8071M0K1 1017760 8071M0K1 1017761 8071M0K1 1017762 8071M0K1 1017763 8071M0K1 1017764 8071M0K1 1017765 8071M0K1 1017766 8071M0K1 1017799 8071M0K1 1017800 8071M0K1 1017801 8071M0K1 1017802 8071M0K1 1017803 8071M0K1 1017804 8071M0K1 1017805 8071M0K1 1017813 8071M0K1 1017939 8071M0K1 1017940 8071M0K1 1017941 8071M0K1 1017942 8071M0K1 1017943 8071M0K1 1017944 8071M0K1 1017964 8071M0K1 1017965 8071M0K1 1017966 8071M0K1 1017967 8071M0K1 1017968 8071M0K1 1017969 8071M0K1 1017970 8071M0K1 1017971 8071M0K1 1018039 8071M0K1 1018040 8071M0K1 1018041 8071M0K1 1018042 8071M0K1 1018059 8071M0K1 1018060 8071M0K1 1018061 8071M0K1 1018156 8071M0K1 1018157 8071M0K1 1018158 8071M0K1 1018159 8071M0K1 1018160 8071M0K1 1018170 8071M0K1 1018171 8071M0K1 1018172 8071M0K1 1018230 8071M0K1 1018231 8071M0K1 1018232 8071M0K1 1018233 8071M0K1 1018234 8071M0K1 1018235 8071M0K1 1018236 8071M0K1 1018237 8071M0K1 1018238 8071M0K1 1018239 8071M0K1 1018240 8071M0K1 1018241 8071M0K1 1018246 8071M0K1 1018247 8071M0K1 1018248 8071M0K1 1018249 8071M0K1 1018250 8071M0K1 1018251 8071M0K1 1018252 8071M0K1 1018253 8071M0K1 1018254 8071M0K1 1018255 8071M0K1 1018262 8071M0K1 1018263 8071M0K1 1018264 8071M0K1 1018265 8071M0K1 1018408 8071M0K1 1018409 8071M0K1 1018410 8071M0K1 1018411 8071M0K1 1018412 8071M0K1 1018413 8071M0K1 1018425 8071M0K1 1018426 8071M0K1 1018427 8071M0K1 1018428 8071M0K1 1018429 8071M0K1 1018430 8071M0K1 1018547 8071M0K1 1018548 8071M0K1 1018549 8071M0K1 1018551 8071M0K1 1018552 8071M0K1 1018553 8071M0K1 1018562 8071M0K1 1018563 8071M0K1 1018564 8071M0K1 1018565 8071M0K1 1018580 8071M0K1 1018581 8071M0K1 1018582 8071M0K1 1018583 8071M0K1 1018676 8071M0K1 1018677 8071M0K1 1018678 8071M0K1 1018679 8071M0K1 1018693 8071M0K1 1018694 8071M0K1 1018695 8071M0K1 1018696 8071M0K1 1018711 8071M0K1 1018712 8071M0K1 1018713 8071M0K1 1018726 8071M0K1 1018727 8071M0K1 1018728 8071M0K1 1018732 8071M0K1 1018733 8071M0K1 1018734 8071M0K1 1018852 8071M0K1 1018853 8071M0K1 1018854 8071M0K1 1018855 8071M0K1 1018858 8071M0K1 1018859 8071M0K1 1018860 8071M0K1 1018861 8071M0K1 1018862 8071M0K1 1018866 8071M0K1 1018867 8071M0K1 1018868 8071M0K1 1018869 8071M0K1 1018870 8071M0K1 1018871 8071M0K1 1018872 8071M0K1 1018873 8071M0K1 1018880 8071M0K1 1018881 8071M0K1 1018882 8071M0K1 1018883 8071M0K1 1018884 8071M0K1 1018885 8071M0K1 1018886 8071M0K1 1018887 8071M0K1 1019035 8071M0K1 1019036 8071M0K1 1019037 8071M0K1 1019038 8071M0K1 1019040 8071M0K1 1019041 8071M0K1 1019042 8071M0K1 1019166 8071M0K1 1019167 8071M0K1 1019168 8071M0K1 1019169 8071M0K1 1019175 8071M0K1 1019176 8071M0K1 1019177 8071M0K1 1019178 8071M0K1 1019193 8071M0K1 1019194 8071M0K1 1019195 8071M0K1 1019196 8071M0K1 1019197 8071M0K1 1019198 8071M0K1 1019300 8071M0K1 1019301 8071M0K1 1019330 8071M0K1 1019331 8071M0K1 1020104 8071M0K1 1020105 8071M0K1 1022191 8071M0K1 1022192 8071M0K1 1022193 8071M0K1 1022194 8071M0K1 1022195 8071M0K1 1022196 8071M0K1 1022209 8071M0K1 1022435 8071M0K1 1022436 8071M0K1 1022452 8071M0K1 1022453 8071M0K1 1022454 8071M0k1 1022455 8071M0K1 1022570 8071M0K1 1022572 8071M0K1 1022573 8071M0K1 1022574 8071M0K1 1022575 8071M0K1 1022632 8071M0K1 1022712 8071M0K1 1022713 8071M0K1 1022714 8071M0K1 1022715 8071M0K1 1022716 8071M0K1 1022717 8071M0K1 1022747 8071M0K1 1022748 8071M0K1 1022749 8071M0K1 1022750 8071M0K1 1022751 8071M0K1 1022896 8071M0K1 1022897 8071M0K1 1022898 8071M0K1 1022899 8071M0K1 1022900 8071M0K1 1022901 8071M0K1 1022902 8071M0K1 1022903 8071M0k1 1022960 8071M0K1 1022961 8071M0K1 1022962 8071M0K1 1022963 8071M0K1 1022964 8071M0K1 1022982 8071M0K1 1022983 8071M0K1 1022984 8071M0K1 1022985 8071M0K1 1022986 8071M0K1 1022987 8071M0K1 1022988 8071M0K1 1022989 8071M0K1 1022990 8071M0K1 1022991 8071M0K1 1022992 8071M0K1 1022993 8071m0k1 1022994 8071M0K1 1022995 8071M0K1 1023076 8071M0K1 1023077 8071M0K1 1023078 8071M0K1 1023079 8071M0K1 1023080 8071M0K1 1023081 8071M0K1 1023082 8071M0K1 1023083 8071M0K1 1023084 8071M0K1 1023085 8071M0K1 1023173 8071M0K1 1023174 8071M0K1 1023175 8071M0K1 1023181 8071M0K1 1023182 8071M0K1 1023183 8071M0K1 1023184 8071M0K1 1023185 8071M0K1 1023186 8071M0K1 1023187 8071M0K1 1023188 8071M0K1 1023304 8071M0K1 1023305 8071M0K1 1023306 8071M0K1 1023307 8071M0K1 1023308 8071M0K1 1023309 8071M0K1 1023310 8071M0K1 1023311 8071M0K1 1023312 8071M0K1 1023313 8071M0K1 1023314 8071M0K1 1023315 8071M0K1 1023316 8071M0K1 1023317 8071M0K1 1023475 8071M0k1 1023476 8071M0K1 1023493 8071M0K1 1023494 8071M0K1 1023495 8071M0K1 1023496 8071M0K1 1023497 8071M0K1 1023498 8071M0K1 1023499 8071M0K1 1023500 8071M0K1 1023508 8071M0K1 1023509 8071M0K1 1023600 8071M0K1 1023601 8071M0K1 1023602 8071M0K1 1023603 8071M0K1 1023634 8071M0K1 1023643 8071m0k1 1023644 8071M0K1 1023645 8071M0K1 1023646 8071M0K1 1023647 8071M0K1 1023648 8071M0K1 1023649 8071M0K1 1023650 8071M0K1 1023651 8071M0K1 1023652 8071M0K1 1023653 8071M0K1 1023654 8071M0K1 1023734 8071M0K1 1023735 8071M0K1 1023736 8071M0K1 1023737 8071M0K1 1023738 8071M0K1 1023753 8071M0K1 1023881 8071M0K1 1023882 8071M0K1 1023883 8071M0K1 1023884 8071M0K1 1023885 8071M0K1 1023886 8071M0K1 1023888 8071M0K1 1023889 8071M0K1 1023890 8071M0K1 1023978 8071M0k1 1023979 8071M0k1 1023980 8071M0K1 1023981 8071M0K1 1023982 8071M0K1 1024005 8071M0K1 1024006 8071M0K1 1024007 8071M0K1 1024008 8071M0K1 1024009 8071M0K1 1024118 8071M0K1 1024119 8071M0K1 1024120 8071M0K1 1024121 8071M0K1 1024122 8071M0K1 1024123 8071M0K1 1024124 8071M0K1 1024125 8071M0K1 1024140 8071M0K1 1024141 8071M0K1 1024142 8071M0K1 1024143 8071M0K1 1024144 8071M0K1 1024145 8071M0K1 1024146 8071M0K1 1024147 8071M0K1 1024148 8071m0k1 1024149 8071M0K1 1024150 8071M0K1 1024254 8071M0K1 1024255 8071M0K1 1024256 8071M0K1 1024257 8071M0K1 1024258 8071M0K1 1024259 8071M0K1 1024260 8071M0K1 1024261 8071M0K1 1024262 8071M0K1 1024263 8071M0K1 1024264 8071M0k1 1024395 8071M0K1 1024396 8071M0K1 1024397 8071M0K1 1024398 8071M0K1 1024399 8071M0K1 1024400 8071M0K1 1024401 8071M0K1 1024402 8071M0K1 1024567 8071M0k1 1024568 8071M0K1 1024569 8071M0K1 1024610 8071M0K1 1024611 8071M0k1 1024612 8071M0K1 1024741 8071M0K1 1024749 8071M0K1 1024863 8071M0K1 1024864 8071M0K1 1024865 8071M0K1 1024866 8071M0K1 1024999 8071M0K1 1025107 8071M0K1 1025108 8071M0k1 1025109 8071M0K1 1025110 8071M0K1 1025111 8071M0K1 1025112 8071M0K1 1025113 8071M0K1 1025122 8071M0K1 1025123 8071M0K1 1025124 8071M0k1 1025125 8071M0K1 1025126 8071M0K1 1025127 8071M0K1 1025128 8071M0K1 1025129 8071M0K1 1025130 8071M0k1 1025131 8071M0K1 1025132 8071M0K1 1025133 8071M0K1 1025134 8071M0K1 1025135 8071M0K1 1025136 8071M0K1 1025138 8071M0K1 1025917 8071M0K1 1025918 8071M0K1 1025919 8071M0K1 1025920 8071M0K1 1025932 8071M0K1 1025933 8071M0K1 1025934 8071M0K1 1025935 8071M0K1 1025936 8071M0K1 1025941 8071M0K1 1025989 8071M4K1 1017460 8071M4K1 1018062 8071M4K1 1018270 8071M4K1 1019039 8071M4K1 1020026 8071M4K1 1020027 8071M4K1 1023765 8071M4K1 1023766 8071M4K1 1023767 8071M5 1017341 8071M5 1017342 8071M5 1017343 8071M5 1017344 8071M5 1017345 8071M5 1017574 8071M5 1017818 8071M5 1017819 8071M5 1017820 8071M5 1017821 8071M5 1017822 8071M5 1017823 8071M5 1017935 8071M5 1017936 8071M5 1017937 8071M5 1017938 8071M5 1017960 8071M5 1017961 8071M5 1017962 8071M5 1017963 8071M5 1018063 8071M5 1018064 8071M5 1018065 8071M5 1018066 8071M5 1018163 8071M5 1018164 8071M5 1018165 8071M5 1018167 8071M5 1018168 8071M5 1018169 8071M5 1018266 8071M5 1018267 8071M5 1018268 8071M5 1018401 8071M5 1018402 8071M5 1018545 8071M5 1018546 8071M5 1018566 8071M5 1018567 8071M5 1018584 8071M5 1018585 8071M5 1018586 8071M5 1018587 8071M5 1018714 8071M5 1018715 8071M5 1019043 8071M5 1019044 8071M5 1019045 8071M5 1019046 8071M5 1019047 8071M5 1019048 8071M5 1019173 8071M5 1019174 8071M5 1019191 8071M5 1019192 8071M5 1019315 8071M5 1019316 8071M5 1019317 8071M5 1019318 8071M5 1022444 8071M5 1022752 8071M5 1022753 8071M5 1022754 8071M5 1022755 8071M5 1022756 8071M5 1022757 8071M5 1022965 8071M5 1022966 8071M5 1022967 8071M5 1022968 8071M5 1022969 8071M5 1023075 8071M5 1023468 8071M5 1023469 8071M5 1023478 8071M5 1023479 8071M5 1023480 8071M5 1023481 8071M5 1023490 8071M5 1023491 8071M5 1023503 8071M5 1023504 8071M5 1023505 8071M5 1023506 8071M5 1023510 8071M5 1023511 8071M5 1023512 8071M5 1023596 8071M5 1023597 8071M5 1023598 8071M5 1023599 8071M5 1023754 8071M5 1023755 8071M5 1023756 8071M5 1023757 8071M5 1023906 8071M5 1023907 8071M5 1023908 8071M5 1023909 8071M5 1023910 8071M5 1023911 8071M5 1023973 8071M5 1023974 8071M5 1023975 8071M5 1023976 8071M5 1023977 8071M5 1024000 8071M5 1024001 8071M5 1024002 8071M5 1024003 8071M5 1024004 8071M5 1024126 8071M5 1024127 8071M5 1024128 8071M5 1024129 8071M5 1024130 8071M5 1024131 8071M5 1024132 8071M5 1024151 8071M5 1024152 8071M5 1024153 8071M5 1024154 8071M5 1024267 8071M5 1024268 8071M5 1024269 8071M5 1024270 8071M5 1024271 8071M5 1024272 8071M5 1024273 8071M5 1024403 8071M5 1024404 8071M5 1024405 8071M5 1024406 8071M5 1024407 8071M5 1024408 8071M5 1024409 8071M5 1024540 8071M5 1024541 8071M5 1024542 8071M5 1024613 8071M5 1024710 8071M5 1024711 8071M5 1024740 8071M5 1024741 8071M5 1024742 8071M5 1024743 8071M5 1025657 8071M5 1025928 8071M5 1025929 8071M5 1025930 8071M5 1025931 8071M9 1022558 8071M9 1022559 8071M9 1022560 8071M9 1022561 8071M9 1022562 8071M9 1022563 8071M9 1022564 8071M9 1022565 8071M9 1022566 8071M9 1022567 8071M9 1022568 8071M9 1022569 8071M9 1023329 8071M9 1023330 8071M9 1023331 8071M9 1023332 8071M9 1023333 8071M9 1023334 8071M9 1023335 8071M9 1023336 8071M9 1023337 8071M9 1023482 8071M9 1023483 8071M9 1023484 8071M9 1023912 8071M9 1023913 8071M9 1024559 8071M9 1024560 8071M9 1024561 8071M9 1024562 8071M9 1024563 8071M9 1024564 8071M9 1024604
RECALLING FIRM/MANUFACTURER
Merz Aesthetics, Inc., Franksville, WI, by letter dated August 15, 2011. Firm initiated recall is ongoing.
REASON
There is a potential leakage of product that may occur with Merz Aesthetics 1.5cc syringes of Radiesse Dermal Filler. When using the syringe, Health Care Professionals should be alerted to the potential for product that my leak pass the plunger at the proximal end of the syring. The defect may result in infection requiring medical intervention to prevent impairment or damage. To date Merz has not received reports of any adverse events linked to the use of the syringes with this defect.
VOLUME OF PRODUCT IN COMMERCE
311,582 units
DISTRIBUTION
Nationwide, Puerto Rico, Dominican Republic, Hong Kong, Israel, Netherlands, Germany, South Korea, and Canada
___________________________________
PRODUCT
Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK. Angiographic syringe intended to be used for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomagraphy. Recall # Z-0147-2012
CODE
Lot # 112865
RECALLING FIRM/MANUFACTURER
Medrad Inc, Indianola, PA, by letter dated October 24, 2011, Firm initiated recall is ongoing.
REASON
Packaging may exhibit open seals - sterility compromised.
VOLUME OF PRODUCT IN COMMERCE
17,380 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209. Recall # Z-0184-2012
CODE
Lot #B051111
RECALLING FIRM/MANUFACTURER
Greiner Bio-One North America, Inc., Monroe, NC, by letter on August 11, 2011. Firm initiated recall is ongoing.
REASON
Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills.
VOLUME OF PRODUCT IN COMMERCE
504,000 pieces
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS
___________________________________
PRODUCT
BD Microtainer MAP Microtube for Automated Process with K2EDTA. For the collection, transport, and automated processing of skin punctures samples from infants, children, geriatric, oncology, and critical care patients. Catalog # 363706. Z-0176-2012
CODE
Lot # 1018904
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Company, Franklin Lakes, NJ, by on-site visit on February 11, 2011, Firm initiated recall is complete
REASON
BD Microtainer MAP Microtube is being recalled due to the potential clotting of blood specimens resulting from a reduced amount of EDTA additive.
VOLUME OF PRODUCT IN COMMERCE
16,400 units
DISTRIBUTION
FL
 
END OF ENFORCEMENT REPORT FOR NOVEMBER 23, 2011
 
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