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U.S. Department of Health and Human Services

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Enforcement Report for October 12, 2011

 

 
October 12, 2011                                                                                        11-41
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
1) Prolab Pure Whey Wild Strawberry 2 lb and 5 lb. Item # P1369. Recall # F-1839-2011;
 
2) Prolab Pure Whey Vanilla Crème 2 lb. Item # P1366 and P1483. Recall # F-1840-2011
CODE
1) Lot# - Date Manufactured F0301 06/2010 F0301AR 06/2010 G1345 07/2011 F0304A 06/2010 D1241 04/2011 D1242 04/2011 D1243 04/2011 C1372 04/2011;
 
2) Lot # - Date Manufactured F0296A 06/2010 F0377A 07/2010 F0296AR 07/2010 G1344 07/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Natrol Inc., Chatsworth, CA, by telephone beginning September 7, 2011.
Manufacturer: Nature's Products, Inc., Sunrise, FL. FDA initiated recall is ongoing.
REASON
Products contain the allergen wheat, however wheat is not declared on the product label.
VOLUME OF PRODUCT IN COMMERCE
1) 14,884 bottles; 2) 10,278 bottles
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Narala Bakery brand HALAL PLAIN CAKE, 1.5 lbs. The product is packaged in a sealed clear plastic bag. Recall # F-1891-2011;
 
2) Narala Bakery brand HALAL FRUIT CAKE. The product is packaged in a sealed clear plastic bag. Recall # F-1892-2011
CODE
Uncoded
RECALLING FIRM/MANUFACTURER
Narala Bakery Inc., Brooklyn, NY, by telephone and Consumer Alert on May 20, 2011. New York initiated recall is complete.
REASON
The product was found to contain undeclared eggs based on sampling, analysis, and inspectional findings by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY City
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) Quick Foods All Natural BEEF KEBAB PITA with Pita Bread, Ground, Beef, Pepper, Salt, Sumac, Lettuce, Tomato, Onion sandwiches in 4 oz and 7 oz packages. Recall # F-1777-2011;
 
2) Quick Foods HONEY MUSTARD CHICKEN BREAST with Bun, 100% Chicken Breast, Provolone, Cheese, Honey Mustard sandwiches in 5.5 oz package. Recall # F-1778-2011;
 
3) Quick Foods Fresh Quality Since 1983 CLASSIC TURKEY SUB with bun, Turkey Breast, Swiss Cheese, Lettuce, Tomato sandwiches in 9 oz plastic packaging. Recall # F-1779-2011;
 
4) Quick Foods CHICKEN QUESADILLA PITA sandwich with Pita, Chicken, Cheddar, Mozzarella, Taco Spices in 5.5 oz packaging. Recall # F-1780-2011;
 
5) Quick Foods Fresh Quality Since 1983 CHEESEBURGER with Bun, Beef Patty, American Cheese sandwiches in 4.25 oz packaging. Recall # F-1781-2011;
 
6) Quick Foods Fresh Quality Since 1983 PHILLY BEEF STEAK with Bun, Beef, Provolone Cheese, Onion, Green Pepper, Pepper Seasoning sandwiches in 7 oz plastic packaging. Recall # F-1782-2011;
 
7) Quick Foods Fresh Quality Since 1983 PHILLY SUPER BEEF STEAK with Bun, Beef, Provolone Cheese, Onion, Green Pepper, Pepper Seasoning sandwiches in 9 oz plastic packaging. Recall # F-1783-2011;
 
8) Quick Foods New! Since 1983 BEEF & BIRD sandwiches with Bun, Roast Beef, Turkey, Swiss Cheese in 9 oz plastic packaging. Recall # F-1784-2011;
 
9) Quick Foods Fresh Quality Since 1983 SUPER HAM & CHEESE sandwiches with Sub Bun, Ham, American Cheese in 9 oz plastic packaging. Recall # F-1785-2011;
 
10) Quick Foods Fresh Quality Since 1983 TURKEY & SWISS ON CIABATTA BREAD sandwiches with Ciabatta Bread, Lettuce, Turkey, Swiss in 6 oz plastic. Recall # F-1786-2011;
 
11) Quick Foods CORNED BEEF & SWISS sandwiches with Rye Bread, Corned Beef, Swiss Cheese, Dijon Mustard in 6.5 oz plastic packaging. F-1787-2011;
 
12) Quick Foods CORNED BEEF & SWISS sandwiches with Rye Bread, Corned Beef, Swiss Cheese in 7 oz plastic packaging. Recall # F-1788-2011;
 
13) Quick Foods Fresh Quality Since 1983 BBQ BEEF sandwiches with Bun, Beef Patty, BBQ Sauce 6 oz plastic packaging. Recall # F-1789-2011;
 
14) Quick Foods DOUBLE CHEESEBURGER sandwiches with Bun, Beef Patty, American Cheese 7 oz plastic packaging. Recall # F-1790-2011;
 
15) Quick Foods Fresh Quality Since 1983 SKINLESS POLISH SAUSAGE SANDWICH $1.29 sandwiches with Bun, Polish Sausage, American Cheese 4.5 oz plastic packaging. Recall # F-1791-2011;
 
16) Quick Foods Fresh Quality Since 1983 TURKEY PITA sandwiches with Pita Bread, Turkey, Swiss Cheese 7 oz plastic packaging. Recall # F-1792-2011;
 
17) Quick Foods CHICKEN PARMESAN sandwiches with Pita, Chicken, Mozzarella, Pizza Sauce, Provolone Cheese 8 oz plastic packaging. Recall # F-1793-2011;
 
18) Quick Foods CHICKEN & CHEESE sandwiches with Bun, Chicken Patty, American Cheese 6 oz plastic packaging. Recall # F-1794-2011;
 
19) Quick Foods Fresh Quality Since 1983 HAM & CHEESE sandwiches with Sub Bun, Ham, American Cheese in 7 oz plastic package. Recall # F-1795-2011;
 
20) Quick Foods COMBO PITA sandwiches with Pita Bread, Ham, Bologna, Salami, American Cheese, Swiss Cheese in 8 oz plastic package. Recall # F-1796-2011;
 
21) Quick Foods Fresh Quality Since 1983 CLUB PITA sandwiches with Pita Bread, Ham, Turkey, American Cheese, Swiss Cheese in 6 oz plastic package. Recall # F-1797-2011;
 
22) Quick Foods Fresh Quality Since 1983 TURKEY & SWISS sandwiches with Sub Bun, Turkey, Swiss Cheese in 7 oz plastic package. Recall # F-1798-2011;
 
23) Quick Foods Fresh Quality Since 1983 SUPER ROAST BEEF sandwiches with Bun, Roast Beef, American cheese in 9 oz plastic package. Recall # F-1799-2011;
 
24) Quick Foods Fresh Quality Since 1983 SUPER TURKEY & CHEESE SUB sandwiches with Sub Bun, Turkey, Provolone Cheese in 9 oz plastic package. Recall # F-1800-2011;
 
25) Quick Foods Fresh Quality Since 1983 ITALIAN SUB sandwiches with Sub Bun, Ham, Hard Salami, Provolone Cheese, Pepper Rings, Lettuce, Tomato, Oregano in 7 oz plastic package. Recall # F-1801-2011;
 
26) Quick Foods Fresh Quality Since 1983 SUPER ITALIAN SUB sandwiches with Sub Bun, Ham, Hard Salami, Provolone Cheese, Pepper Rings, Lettuce, Tomato, Oregano in 9 oz plastic package. Recall # F-1802-2011;
 
27) Quick Foods Fresh Quality Since 1983 SUBMARINE sandwiches with Bun, Salami, Bologna, American Cheese, Ham, Pepper Rings in 7 oz plastic package. Recall # F-1803-2011;
 
28) Quick Foods CHICKEN SALAD sandwiches with Wheat Bread, Chicken, Mayonnaise, Celery, Hot Pepper Rings, Salt, Pepper in 6.5 oz plastic package. Recall # F-1804-2011;
 
29) Quick Foods Fresh Quality Since 1983 SUPER DELUXE TURKEY sandwiches with Bun, Turkey Breast, Hard Salami, Provolone Cheese, Lettuce, Tomato, Pepper Rings in 9 oz plastic package. Recall # F-1805-2011;
 
30) Quick Foods Fresh Quality Since 1983 GIANT SUBMARINE sandwiches with Bun, Salami, Bologna, Pepperoni, American Cheese, Ham, Pepper Rings in 10 oz plastic package. Recall # F-1806-2011;
 
31) Quick Foods Fresh Quality Since 1983 CLASSIC ITALIAN ON CIABATTA BREAD sandwiches with Ciabatta bread, Salami, Cappacuolo, Pepper Jack Cheese, Provolone Cheese, Pepper Rings in 7 oz plastic package. Recall # F-1807-2011
CODE
All codes produced 7/26/2011 - 08/10/2011.
RECALLING FIRM/MANUFACTURER
Quick Food Co., Ferndale, MI, by visit on August 3, 2011. FDA initiated recall is ongoing.
REASON
Wheat is used as an ingredient and is not declared on the ingredient declaration. Yellow #5 is used in the pepper rings and is not identified as the ingredient declaration.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
MI
___________________________________
PRODUCT
1) Prolab Pure Whey Milk Chocolate 16g, 2 lb, 5 lb. Item # P1365 – a) 5 lb; b) Item # P1365-S and 1365 16g and 2 lb. Recall # F-1838-2011;
 
2) Prolab Advanced Pure Whey Milk Chocolate 2 lb. Item # P1387. F-1841-2011;
 
3) Prolab Advanced Pure Whey Wild Strawberry 2 lb. Item # P1385. Recall # F-1842-2011;
 
4) Prolab Advanced Pure Whey Vanilla Crème 2 lb. Item # P1386. F-1843-2011;
 
5) Prolab Pure Whey Wild Strawberry 16 g. Item # P1369-S. Recall # F-1844-2011;
 
6) Prolab Pure Whey Vanilla Crème 16 g and 5 lb. Item # P1369-S and P1369. Recall # F-1845-2011;
 
7) Prolab Whey Isolate Milk Chocolate 2 lb. Item # P1370. Recall # F-1846-2011;
 
8) Prolab Whey Isolate Wild Strawberry 2 lb. Item # P1370. Recall # F-1847-2011;
 
9) Prolab Whey Isolate Vanilla Crème 2 lb. Item # P1368. Recall # F-1848-2011
CODE
1) a) Lot# - Date Manufactured F0383A 07/2010 D1227-1 04/2011 D1228 04/2011 D1229 04/2011 D1230 04/2011 D1231 04/2011 D1232 04/2011 G1336-1 07/2011 G1337 07/2011 G1338 07/2011 G1339 07/2011 G1340 07/2011 G1341 07/2011 Item # P1365-S and P1365; b) Lot# - Date Manufactured I0390A 07/2010 K0171A 01/2011 F0323A 07/2010 F0312A 07/2010 F0442A 07/2010 D1226 04/2011 D1227 04/2011 E1050 06/2011 E1348-1 06/2011 E1350 06/2011 E1349 06/2011 E1351 06/2011 E1352 06/2011 E1353 06/2011 G1336 06/2011;
 
2) Lot# - Date Manufactured A1297 02/2011 A1298 02/2011 D1254 08/2011;
 
3) Lot# - Date Manufactured A1295 01/2011 A1296 01/2011 D1251 08/2011 D1252 08/2011 D1253 08/2011;
 
4) Lot# - Date Manufactured A1292 01/2011 A1293 01/2011;
 
5) Lot # - Date Manufactured L0239A 01/2011 L0239B 01/2011;
 
6) Lot # - Date Manufactured L0239A 01/2011 L0239B 01/2011;
 
7) Lot # - Date Manufactured K0318A 11/2010 A1291A 01/2011 D1244 05/2011;
 
8) Lot # - Date Manufactured K0318A 11/2010 A1291A 01/2011 D1244 05/2011;
 
9) Lot # - Date Manufactured K0317A 11/2010 A1288 01/2011 A1289 01/2011 A1290 01/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Natrol Inc., Chatsworth, CA, by telephone beginning September 7, 2011.
Manufacturer: Nature's Products, Inc., Sunrise, FL. FDA initiated recall is ongoing.
REASON
Products contain the allergen wheat, however wheat is not declared on the product label.
VOLUME OF PRODUCT IN COMMERCE
1) 5 lb - 8,490 bottles; 16g - 25,004 bottles; 1 lb - 18.463 bottles
2) 3,715 bottles
3) 4,591 bottles
4) 2,137 bottles
5) 24, 683 packets
6) 25,652 16g packets; 13, 451 5 lb bottles
7) 3,500 bottles
8) 2,265 bottles
9) 2,660 bottles
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
"***SunnyBoy Creamy Peanut Butter***Ingredients: Peanuts, Dextrose, Contains less tha 2% of the following: Salt, Partially Hydrogenated Oil (Rapeseed Cottonseed And/Or Mono-Diglycerides)***Allergen Statement: Contains Peanuts***Net Wt. 5lb. (2.27KG)***Product of USA***". Recall # F-0002-2012
CODE
Unit: 050512
RECALLING FIRM/MANUFACTURER
Sunshine Peanut Co., Jacksonville, FL, by telephone on July 26, 2011 and by letter on July 27, 2011. FDA initiated recall is ongoing.
REASON
The product contains elevated levels of aflatoxins.
VOLUME OF PRODUCT IN COMMERCE
1,344 cases
DISTRIBUTION
NY
___________________________________
PRODUCT
1) Red Cherry Mamey Color Product: ***Medina Brand Red Cherry Mamey (Food Color) Ingredients: Water, Propylene Glycol, FDC Artificial Colors, 6% Concentration. Net 32 Fl ozs. (One quart). Red Cherry Mamey mislabeled for Red #40, Red #3, Yellow #6. Product was packaged in quart and gallon containers. Recall # F-0004-2012;
 
2) Egg Shade 6% Product: ***Medina Brand Egg Shade 6% (Food Color) Ingredients: Water. Propylene Glycol, FD&C YELLOW #5 Red #40, Caramel Color, Artificial Coloring Net Contents 128 Fl. oz. (1 Gallon). Egg Shade 6% is mislabeled for Yellow #6. Product is packaged in quart containers. Recall # F-0006-2012;
 
3) Egg Shade 4% Product: ***Medina Brand Egg Shade 4% (Food Color) Ingredients: Water, Propylene Glycol, FD&C Yellow #5, Red #40, Caramel Color, Artificial Coloring Net Contents 128 Fl. oz. (1 Gallon). *** Egg Shade 4% mislabeled for Yellow #6. Recall # F-0007-2012
CODE
1) Production dates: 2/11, 4/1, 4/19, 6/10, 7/16, 8/13, 9/29, 11/4, 12/9;
2) Production dates: 2/15, 3/5, 5/4, 7/7, 8/25, 11/9, 11/30;
3) Production Dates: 3/3 4/7, 4/27, 5/10, 6/4, 7/1, 7/4, 7/13, 8/12, 8/27, 9/13, 9/23, 10/01, 10/14, 11/8, 11/24, 12/16
RECALLING FIRM/MANUFACTURER
Medina Baking & Powder Products, Inc., Miami, FL, by letter on December 17, 2010. FDA Initiated recall is ongoing.
REASON
The product contains undeclared color - FD&C Yellow # 6, FD&C Red # 3, and FD&C Red # 40.
VOLUME OF PRODUCT IN COMMERCE
1) 284 gal; 195 qts
2) 180 qts
3)1355 gal
DISTRIBUTION
FL
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
1) Orange Color Product: "***MEDINA BRAND ORANGE (FOOD COLOR) INGREDIENTS: WATER, PROPYLENE GLYCOL, ARTIFICIAL COLORS, FD&C YELLOW #5 and YELLOW #6. NET 32 FL, OZS." Orange Food Color mislabeled for Red #40. Product is packed in quart containers. Recall # F-0003-2012;
 
2) Mantecado Flavor: "***MEDINA BRAND***ARTIFICIAL FLAVOR Mantecado INGREDIENTS: WATER, GLYCOL, VAINILLIN, ETHYL VAINILLIN, EGG YOLK, DOLCOTONE, ARTIFICIAL CINNAMON OIL, ARTIFICIAL NUTMEG OIL, VEGETABLE GUM, FD&C COLORS, YELLOW #5. 8 Oz. MILKCREAM SHAKES: 1 Tea Spoon Mantecado, 1 Egg Whole, 8 Oz. Ice, 2 Spoon Sugar, Salt Your Taste. ***ICE CREAM: 1 Tea Spoon Mantecado, 4 Egg Whole, 1/4 Gallon Milk Cream, 4 Oz. Corn Starch, 8 Oz. Sugar, Salt Your Taste (Cookcorn with 1/4 of water). NET CONTENTS: 128 FL. Oz. (1 GALLON). ***" Mantecado artificial flavor is mislabeled for Blue #1 Red #40. Product was packaged in gallon and quart containers. Recall # F-0005-2012;
 
3) Green Peppermint Color Product: "***MEDINA BRAND Green Peppermint Color. INGREDIENTS: WATER, PROPYLENE GLYCOL, FD&C ARTIFICIAL COLOR, YELLOW #5 6% CONCENTRATION. NET CONTENTS 32 FL. OZS. (1 QUART)." Green Peppermint Color mislabeled for Blue #1. Product was packaged in quart containers. Recall # F-0008-2012;
 
4) Red Rose Color Product: "***MEDINA BRAND Red Rose Color Color Rosa Brillante (FOOD COLOR) INGREDIENTS: WATER, PROPYLENE GLYCOL, FD&C ARTIFICIAL COLOR, 6% CONCENTRATION. NET 32 FL. OZS. (ONE QUART) RR.” Red Rose Color mislabeled for Red #3. Recall # F-0009-2012
CODE
1) Production Date: 9/15;
2) Product dates: 2/11, 3/3, 4/23, 6/18, 7/26, 9/7, 10/04, 11/29;
3) Production Dates: 4/14, 5/17, 9/17, 11/15;
4) Production dates: 2/24, 5/4, 7/8, 9/20, 12/9
RECALLING FIRM/MANUFACTURER
Medina Baking & Powder Products, Inc., Miami, FL, by letter on December 17, 2010. FDA Initiated recall is ongoing.
REASON
The product contains undeclared color - FD&C Blue # 1, FD&C Red # 40 and Red # 3.
VOLUME OF PRODUCT IN COMMERCE
1) 108 qts
2) 691 gals; 21 qts
3) 301 qts
4) 475 qts
DISTRIBUTION
FL
 
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 Recall Pending Classifications for this week.
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II 
__________________________________
PRODUCT
Cyclobenzaprine HCl Tablets USP, 10 mg, a) 100-count bottles, NDC: 50111-563-01, b) 500-count bottles, NDC: 50111-563-02, & c) 1000-count bottles, NDC: 5011-563-03, Rx only. Recall # D-001-2012
CODE
Lot #s: a) 702863, Exp 6/2012; b) 702830, Exp 6/2012, 702864, Exp 7/2012; c) 702831, Exp 7/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on August 9, 2011.
Manufacturer: Pliva Krakow S.A., Krakow, Poland. Firm initiated recall is ongoing.
REASON
Labeling: Label w/ wrong or incorrect expiration date.
VOLUME OF PRODUCT IN COMMERCE
46,589 Bottles
DISTRIBUTION
Nationwide and PR
__________________________________
PRODUCT
1) Aminophylline Tablets USP Rx only 100 mg tablets NDC 0143-1020-01. Recall # D-223-2012;
 
2) Aminophylline Tablets USP Rx only 1000 mg NDC 0143-1020-10. Recall # D-224-2012
CODE
1) 100s 66383B FEB 2013 66557A MAY 2013 67297B JAN2014 67921A JAN2014;
 
2) 1000s 66382A FEB 2013 66383A FEB 2013 66557B MAY 2013 67296A JAN 2014 67297A JAN2014 67921B June2014 67922A June2014
RECALLING FIRM/MANUFACTURER
West-ward Pharmaceutical Corp., Eatontown, NJ, by letters dated May 19, 2011. Firm initiated recall is ongoing.
REASON
Stability data does not support exp; failed assay and content uniformity results at 24-month test interval.
VOLUME OF PRODUCT IN COMMERCE
44,127 bottles
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Tylenol 8 HR Caplets (Acetaminophen Extended Release Pain Reliever/Fever Reducer), 650 mg Caplets, 150-count bottle, NDC 50580-297-15. Recall # D-314-2012
CODE
Lot # ADM074; Exp 03/31/12
RECALLING FIRM/MANUFACTURER
McNeil Consumer Healthcare, Div Of Mcneil-ppc, Inc., Fort Washington, PA, by letters on March 29, 2011. Firm initiated recall is ongoing.
REASON
Chemical Contamination; Presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA).
VOLUME OF PRODUCT IN COMMERCE
34,056 bottles
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Extended Phenytoin Sodium Capsules, USP, 100mg, Rx only, packaged in a) 100UD (10 x 10-count blisters) per carton, NDC 68084-376-01, barcode 6808437601; each 10-count blister (barcode 6808437611), AHP item # 037601; b) 100UD (100 Bags of One Capsule Each), over-bagged with labeled clear plastic APS bags, NDC 68084-376-01, UPC 3 6808437601 6. Recall # D-316-2012
CODE
a) Lot #102144, 102145, 03/12; 102740, 102862, 102859, Exp 05/12; b) 102470RP, 990163, Exp 05/12.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, by letter on August 23, 2011.
Manufacturer: Amneal Pharmaceuticals of New York, LLC, Hauppauge, NY. Firm initiated recall is ongoing.
REASON
Unit Dose Mispackaging: Blister packs may contain more than one capsule in the individual blister pack cavities.
VOLUME OF PRODUCT IN COMMERCE
11,384 blister packs
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
1) Tylenol(R) Cold Multi-Symptom Nighttime Rapid Release Gels 24 RR Gelcaps, NDC 50580-395-24. Recall # D-381-2012;
 
2) Tylenol(R) Cold Multi-Symptom Rapid Release Gels Day/Night 12+8 RR Gelcaps, NDC 50580-396-20. Recall # D-382-2012;
 
3) Tylenol(R) Cold Multi-Symptom Rapid Release Gels Day/Night 36+24 RR Gelcaps, NDC 50580-396-60. Recall # D-383-2012
CODE
1) Lot numbers: AMA277, exp 8/31/2011; APA059, exp 8/31/2011; APA162, exp 8/31/2011; ASA025, exp 8/31/2011; APA237, exp 9/30/2011; ASA072, exp 9/30/2011; ASA208, exp 9/30/2011; and BAA008, exp 10/31/2011;
 
2) Lot numbers: AMF034, exp 8/31/2011; BAF005, exp 9/30/2011; BAF027, exp 10/31/2011; and BCF080, exp 10/31/2011;
 
3) Lot numbers: BBF001, exp 10/31/2011; BCF060, exp 10/31/2011; and BCF079, exp 2011
RECALLING FIRM/MANUFACTURER
McNeil Consumer Healthcare, Div Of Mcneil-ppc, Inc., Fort Washington, PA, by letter on August 15, 2011. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products; the level of Chlorpheniramine Ammonio Acetate (CPAA) was slightly higher than expected in some TYLENOL(R) Cold Multi-Symptom Nighttime Rapid Release Gelcaps.
VOLUME OF PRODUCT IN COMMERCE
2,372,472 cartons
DISTRIBUTION
Nationwide and PR
__________________________________
PRODUCT
ProAir HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg/ per actuation, 200 metered actuations, 8.5 g inhaler, Rx only, NDC 59310-579-20; UPC 3 59310-579-20 2. Recall # D-675-2012
CODE
Lot #: PAA35A, PAA35B, and PAA35C; Exp 05/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on August 30, 2011.
Manufacturer: Teva Pharmaceuticals Limited, Waterford, Ireland. Firm initiated recall is ongoing.
REASON
Does Not Deliver Proper Metered Dose: Some canisters have the potential to leak.
VOLUME OF PRODUCT IN COMMERCE
571,817 inhalers
DISTRIBUTION
Nationwide and PR
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III 
___________________________________
PRODUCT
Budeprion XL (Bupropion HCl ER Tablets) 300 mg, RX only, 500 tablets, NDC # 0093-5351-05. Recall # D-225-2012
CODE
Lot 9020881, 9020891, 9020911, 9020931, 9020951, 9020971, 9020991, 9021081, Exp. 2/28/2011; 9021121, Exp. 3/31/2011; H0040361, H0040372, Exp. 3/31/2012; H0070781, H0070791, Exp. 7/31/2012; and H0100391, Exp. 9/30/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on January 31, 2011. 
Manufacturer: Impax Laboratories, Inc., Hayward, CA. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Recall is being carried out due to the potential that lots may not meet impurity specification over product shelf life.
VOLUME OF PRODUCT IN COMMERCE
7,718 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II ___________________________________
PRODUCT
Red Blood Cells. Recall # B-2090-11
CODE
Unit: W045611401155
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Erie County, Erie, PA, by telephone on June 28, 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
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2101-11
CODE
Unit: W036511024517
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Texarkana, TX, by letter dated July 29, 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
LA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2102-11
CODE
Units: W036511062952 (2 units), W036511062950
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on May 28, 2011. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled as negative for Cytomegalovirus (CMV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AR
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2103-11
CODE
Unit: W036510073652
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by electronic notification on July 1, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2104-11
CODE
Unit: 16KT23391
RECALLING FIRM/MANUFACTURER
American National Red Cross, Central Ohio Region, Columbus, OH, by facsimile and e-mail on June 22, 2011 and by letter dated June 22, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH, CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-2106-11
CODE
Unit: W045611401154
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Erie County, Erie, PA, by telephone on June 28, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of hepatitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2107-11
CODE
Unit: 42KR16672
RECALLING FIRM/MANUFACTURER
American National Red Cross, Cleveland, OH, by facsimile on June 30, 2011 and by letter dated June 30, 2011. Firm initiated recall is complete.
REASON
Blood product, which may have become contaminated during manufacturing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
1) Red blood cells leukocytes reduced. Recall # B-2108-11;
2) Fresh Frozen Plasma. Recall # B-2109-11;
3) Red blood cells leukocytes reduced irradiated. Recall # B-2111-11
CODE
1) Units: 20E34879, 20E34885, 20E34887, 20E34890, 20E34894, 20E34899, 20E34901, 20E34906, 20E34908, 20E34910, 20J98677, 20J98684, 20J98688, 20J98698, 20J98700, 20J98703, 20J98710, 20J98713, 20J98716, 20J98718, 20J98723, 20J98721, 20M38841, 20M38847, 20M38849, 20M38852, 20M38854, 20M38872, 20M38831, 20M38838, 20M38857, 20M38862, 20M38834, 20M38840, 20M38870, 20M38856, 20M38858, 20M38866, 20M38864, 20M38869, 20V83505, 20V83514, 20V83516, 20V83519, 20V83510, 20V83521;
 
2) Units: 20E34879, 20E34885, 20E34890, 20E34901, 20M38857, 20M38862, 20M38872, 20V83519, 20V83521;
 
3) Unit: 20M38861
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by fax on March 17, 2005. 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
56 units
DISTRIBUTION
CA, NV, OK, TX, UT
___________________________________
PRODUCT
Source Plasma. Recall # B-2139-11
CODE
Units: FZ028939; FZ028797; FZ028332; 06MILA6208; 06MILA6079
RECALLING FIRM/MANUFACTURER
Recalling Firm: Interstate Blood Bank Inc., Memphis, TN, by fax on March 12, 2007.
Manufacturer: Interstate Blood Bank Inc. of Wisconsin, Milwaukee WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had been permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
IL, Switzerland
___________________________________
PRODUCT
Source Plasma. Recall # B-2185-11
CODE
Units: 11MTNA9018; KZ109275; KP125619
RECALLING FIRM/MANUFACTURER
Plasma Biological Services Inc., Memphis TN, by fax and e-mail on July 28, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria, Canada, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2172-11
CODE
Unit: GF80783
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on November 10, 2006. Firm initiated recall is complete.
REASON
Blood product, for which documentation of temperature was unacceptable, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2173-11
CODE
Unit: FN08376
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on January, 22, 2007. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2177-11
CODE
Units: 8347863(part B), 8347868
RECALLING FIRM/MANUFACTURER
Exempla Healthcare St. Joseph Hospital Blood Bank, Denver, CO, by facsimile on July 11, 2007. 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
CO
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2178-11
CODE
Unit: 8273126
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by telephone on October 10, 2009. Firm initiated recall is complete.
REASON
Blood product, which tested positive for unexpected red cell antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2186-11
CODE
Unit: W068511330309
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA,   by letter dated July 15, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area potentially endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Platelets Leukocytes Reduced. Recall # B-2187-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-2188-11
CODE
1) W037710052235;
2) Units: W037710052235; W037710026298
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter dated August 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-2189-11
CODE
Units: W2906110258761; W2906110258763; W2906110258762
RECALLING FIRM/MANUFACTURER
Penrose-St Franc Health Services Blood Bank, Colorado Springs, CO, by telephone on August 11, 2011. Firm initiated recall is complete.
REASON
Blood products, with platelet counts below the specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO
___________________________________
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-2190-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-2191-11
CODE
1) and 2) Unit: W0422110034656
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on August 9, 2011 and follow up letter dated August 15, 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
2 units
DISTRIBUTION
NV
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2192-11
CODE
Unit: W141611415797
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by fax on August 2, 2011.
Manufacturer: Puget Sound Blood Center and Program, Tukwila, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2193-11
CODE
Unit: 042FR67837
RECALLING FIRM/MANUFACTURER
American National Red Cross, Cleveland, OH, by facsimile on June 21, 2010. 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
OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2194-11
CODE
Unit: W035211204867N
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and facsimile on August 9, 2011 and letter on August 22, 2011. 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
TX
___________________________________
PRODUCT
Source Plasma. Recall # B-2195-11
CODE
Unit: 11BOHB644
RECALLING FIRM/MANUFACTURER
Bio-Blood Components Inc., Columbus, OH, by facsimile on July 29, 2011. 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
1) Red Blood Cells. Recall # B-2196-11
2) Plasma Frozen within 24 hours (FP24). Recall # B-2197-11
CODE
1) and 2) Unit: W088611100542
RECALLING FIRM/MANUFACTURER
Providence Health System Southern California, Burbank, CA, by telephone on August 10, 2011. Firm initiated recall is complete.
REASON
Blood products, which were not quarantined subsequent to receiving post donation information, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Plasma Frozen within 24 hours (FP24). Recall # B-2199-11
CODE
Unit: W038111180420
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by facsimile and letter dated August 1, 2011.
Manufacturer: Florida's Blood Centers, Inc., Kissimmee, FL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2200-11
CODE
Units: 8031950, 8030444
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by telephone on July 25, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malaria endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Source Plasma. Recall # B-2013-11
CODE
Units: 4270032436, 4270030596, 4270029489, 4270028664, 4270028310, 4270027673, 4270027371, 4270026781, 4270026433, 4270025857, 4270025552
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Charlotte, NC, by e-mail on July 1, 2011 and July 5, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Austria, CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2100-11
CODE
Unit: 011FT39416
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by facsimile on June 17, 2011 and by letter dated June 17, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2105-11
CODE
Unit: 16KT23391
RECALLING FIRM/MANUFACTURER
American National Red Cross, Central Ohio Region, Columbus, OH, by facsimile and e-mail on June 22, 2011 and by letter dated June 22, 2011. Firm initiated recall is ongoing.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH, CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2110-11
CODE
Units: 20E34894, 20E34899, 20E34906, 20E34908, 20E34910, 20J98677, 20J98684, 20J98688, 20J98698, 20J98700, 20J98703, 20J98710, 20J98713, 20J98716, 20J98718, 20J98721, 20J98723, 20M38831, 20M38834, 20M38838, 20M38840, 20M38841, 20M38847, 20M38849, 20M38852, 20M38854, 20M38856, 20M38858, 20M38861, 20M38864, 20M38866, 20M38869, 20M38870, 20M40659, 20M40662, 20M40664, 20M40674, 20V83505, 20V83510, 20V83514, 20V83516
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by fax on March 17, 2005. 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
41 units
DISTRIBUTION
CA, NV, OK, TX, UT
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2163-11;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2164-11
CODE
1) LM67042, LM43676, LM43654, LM46385, LM43673, LM68227, LM46255, GG08509, LM55508, LM55036, LM68017, LM50173, GG07422, LM35658, LM43576, GG08837, GG08820, LM55339, LM03061, GG09262, LM55906, LM03110, LM03115, LM68935, LM52793, GG07792, LM73986, GG10760, LM76434, LM83565, LM32338, LM54758, LM78423;
 
2) Units: LM63786, LM61716, LM54820, LM75531
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone and facsimile on February 23, 26, 27, 2007 and on March 6, 2007. Firm initiated recall is complete.
REASON
Blood products, which were exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
37 units
DISTRIBUTION
CA, MI
___________________________________
PRODUCT
Source Plasma. Recall # B-2174-11
CODE
Unit: LP185584
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corp, Las Vegas, NV, by facsimile on June 27, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-2175-11
CODE
Unit: LT121071
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corp., Las Vegas, NV, by facsimile on May 23, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Germany
___________________________________
PRODUCT
Source Plasma. Recall # B-2176-11
CODE
Unit: LP184215
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corp., Las Vegas, NV, by facsimile on May 3, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Germany
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2198-11
CODE
Units: W035811129380 (part A), W035811129380 (part B)
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Mather, CA, by telephone on July 13 and 14, 2011. Firm initiated recall is complete.
REASON
Blood products, labels with incorrect or missing information, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
BD MAX DNA Extraction Kit DNA-1 (Urine/Plasma) Catalog Number 437501. Kit contains 24/2D barcode sample preparation reagent tubes ***For use with the BD MAX System *** to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. The specimen is mixed with BD MAX Sample Preparation Reagent and processed using the BD MAX System. The BD MAX System automates DNA extraction and concentration. No operator intervention is necessary once the clinical sample is loaded onto the BD MAX System. The BD MAX DNA Extraction Kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. Purified DNA obtained with the BD MAX DNA Extraction Kits may be analyzed using the BD MAX System or another commercially available system for nucleic acid amplification and detection. BD MAX DNA Extraction Kits have not been validated for use with any specific analytical test method. The BD MAX System uses a combination of lytic and extraction reagents to perform cell lysis, DNA extraction and removal of inhibitors. Following cell lysis, by a combination of heat and lytic enzymes, the released nucleic acid is captured by magnetic affinity beads. The beads, with the bound nucleic acids, are washed and the nucleic acids is eluted using -10 ul of release solution. DNA is neutralized for a final volume of -20 ul. Product Quantity Distributed (Int) 21 kits. Recall # Z-3216-2011;
 
2) BD MAX DNA Extraction Kit DNA-2 (Whole Blood) Catalog Number 437502. Kit contains 24/2D barcode sample preparation reagent tubes *** For use with the BD MAX System ***to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. The specimen is mixed with BD MAX Sample Preparation Reagent and processed using the BD MAX System. The BD MAX DNA Extraction Kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. Purified DNA obtained with the BD MAX DNA Extraction Kits may be analyzed using the BD MAX System or another commercially available system for nucleic acid amplification and detection. BD MAX DNA Extraction Kits have not been validated for use with any specific analytical test method. The BD MAX System uses a combination of lytic and extraction reagents to perform cell lysis, DNA extraction and removal of inhibitors. Following cell lysis, by a combination of heat and lytic enzymes, the released nucleic acid is captured by magnetic affinity beads. The beads, with the bound nucleic acids, are washed and the nucleic acids is eluted using -10 ul of release solution. DNA is neutralized for a final volume of -20 ul. Product Quantity Distributed (Int) 21 kits. Recall # Z-3217-2011;
 
3) BD MAX DNA Extraction Kit DNA-3 (Swabs in Transport Medium/UTM), Catalog Number 437503. Kit contains 24/2D barcode sample preparation reagent tubes ***For use with the BD MAX System *** to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. The specimen is mixed with BD MAX Sample Preparation Reagent and processed using the BD MAX System. The BD MAX System automates DNA extraction and concentration. No operator intervention is necessary once the clinical sample is loaded onto the BD MAX System. The BD MAX DNA Extraction Kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. Purified DNA obtained with the BD MAX DNA Extraction Kits may be analyzed using the BD MAX System or another commercially available system for nucleic acid amplification and detection. BD MAX DNA Extraction Kits have not been validated for use with any specific analytical test method. The BD MAX System uses a combination of lytic and extraction reagents to perform cell lysis, DNA extraction and removal of inhibitors. Following cell lysis, by a combination of heat and lytic enzymes, the released nucleic acid is captured by magnetic affinity beads. The beads, with the bound nucleic acids, are washed and the nucleic acids is eluted using -10 ul of release solution. DNA is neutralized for a final volume of -20 ul. Product Quantity Distributed (Int) 21 kits. Recall # Z-3218-2011;
 
4) BD MAX RNA Extraction Kit RNA-3, Catalog Number 437506. Kit contains 24/2D barcode sample preparation reagent tubes. The BD MAX RNA Extraction Kit is used with the BD MAX System to extract RNA from viruses which maybe present in clinical specimens. Purified RNA obtained with the BD MAX System or another commercially available system for reverse transcription followed by nucleic acid amplification and detection. The BD MAX RNA Extraction Kit has not been validated for use with any specific analytical test method. The BD MAX DNA extraction kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. Recall # Z-3219-2011;
 
5) BD MAX GBS Catalog Number 441772 For In Vitro Diagnostic Use, For use with the BD MAX system.The Sample Preparation Reagent kit consists of 24 (2 x 12) 2D barcode tubes which verifies against the number entered in the worklist with the handheld barcode reader. The BD MAX System is a qualitative in vitro diagnostic test obtained from vaginal and rectal swab specimens from antepartum pregnant women designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to 18 hours. The BD MAX DNA extraction kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens. Recall # Z-3220-2011
CODE
1) Lot numbers 110731, 110831, 111011, 111111;
 
2) Lot numbers 110611, 110901, 111011, 111111;
 
3) Lot numbers 103362, 103551, 103552, 110071, 110072, 110101, 110191, 110281, 110321, 110381, 110561, 110562, 110563, 110771, 110772, 110901, 111111;  
 
4) Lot numbers 103551, 110071, 110381, 110382, 110383, 110841, 110842, 110901, 110902;
 
5) Lot numbers 103271, 103272, 110071, 110072, 110391, 110401, 110521, 110522, 110561, 110562, 110181, 110611, 110941, 110942, 111111
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co, BD Diagnostic Systems, Sparksm, MD, by letter dated May 2011.
Manufacturer: Handylab, Inc, |Ann Arbor, MI. Firm initiated recall is complete.
REASON
Medical device bar code reader does not function as intended and could result in associating clinical test results to wrong patient.
VOLUME OF PRODUCT IN COMMERCE
392 kits - 24 tests each
DISTRIBUTION
Nationwide and Belgium
___________________________________
PRODUCT
ANGIODYNAMICS Angiographic Catheter, Soft-Vu Cobra (2) BRAIDED, 5 F x 90 cm x .035 in., Catalog No./REF 10709105, STERILE. Recall # Z-3259-2011
CODE
Lot 517631, Use By 06/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Angiodynamics Worldwide Headquarters, Latham, NY, by letter dated June 7, 2011.
Manufacturer: Angiodynamics, Inc., Queensbury, NY. Firm initiated recall is ongoing.
REASON
The lot of Soft-Vu Catheters was labeled 90 cm in length; however the product was cut to a 65 cm length.
VOLUME OF PRODUCT IN COMMERCE
30 (Nationwide - 25 units; internationally - 5 units)
DISTRIBUTION
Nationwide and Spain
___________________________________
PRODUCT
1) Angiodynamics Profiler Balloon Dilatation Catheter, Catalog No./REF 16801101, Balloon Diameter 4MM, Balloon Length 2 CM, Catheter Length 40 CM, Sterile, Cardiovascular catheterization. Recall # Z-3261-2011;
 
2) Angiodynamics Profiler Balloon Dilatation Catheter, Catalog No./REF 16801105, Balloon Diameter 5MM, Balloon Length 4 CM, Catheter Length 40 CM, Sterile, Cardiovascular catheterization. Recall # Z-3262-2011
CODE
1) Lot 532109 (Use By 2013-12);
2) Lot 532794 (Use By 2013-12)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Angiodynamics Worldwide Headquarters, Latham, NY, by letter dated February 25, 2011.
Manufacturer: Angiodynamics, Inc., Queensbury, NY. Firm initiated recall is ongoing.
REASON
The particular lots of Profiler PTA Balloon Catheters were labeled incorrectly. Lot 532109 contains product that is actually 5 mm x 4 cm x 40 cm and Lot 532794 contains product that is actually 4 mm x 2 cm x 40 cm.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and be able to deliver therapy. Model numbers: Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198, 2023440. Brand names: Powerheart AED, G3, CardioVive AED, GE Responder AED, Nihon Kohden CardioLife AED. Recall # Z-3265-2011;
CODE
Serial numbers: 022805, 031605, 303024, 322627, 322644, 328877, 900034, 900055, 900061, 900110, and 972196. Serial numbers Ranges: from 900134 through 903240; from 329024 through 394573; from 400001 through 4049272; from 4100002 through 4370573; from 92532-0000501 through 92532-0001310; and from 92533-0000000 through 92533-0001340
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardiac Science Corp., Bothell, WA, by letter on August 1, 2011.
Manufacturer: Cardiac Science Corp., Deerfield, WI. Firm initiated recall is ongoing.
REASON
Cardiac Science Corporation (CSC) has identified two errors, 0x48 and 0x99, that have repeatedly occurred during a device self-test in the G3 installed base over the last 6 years. These self test errors cause the device to enter into a service required state. CSC remind owners/operators of the Powerheart AED devices to verify the "Rescue Readiness" of their equipment and follow maintenance procedures as specified in operation and maintenance guides provided with every AED.
VOLUME OF PRODUCT IN COMMERCE
195,739 units in nationwide; 185,642 units internationally
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Contour, Contour TS Blood Glucose Test Strips and Bonus Packs Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in whole blood. 9545C, 9677, 9678, 9679, 9680, 7151G, 7190, 7183, 9615, 7393, 9591, 9591A, 9579, 1802, 6181, 7070A, 9725, 9507C, and 9578. Contour 125 Count Bonus Pack (includes 2-50 Count and 1-25 Count Vials). Recall # Z-3268-2011
CODE
Lot numbers: DW0AC3B32A, DW0AC3B32C, DW0BC3B31A, DW0BC3B31B, DW0BC3D05B, DW0CC3B31A, DW0CC3B31B, DW0GC3B31C, DW0GC3B31D, DW0GC3B31F, DW0HC3B32A, DW9MC3B32D, DW9MC3B32E, DW9MC3B33A, and DW9MC3B33B
RECALLING FIRM/MANUFACTURER
Bayer Healthcare, LLC, Mishawaka, IN, by letter dated August 12, 2011. Firm initiated recall is ongoing.
REASON
All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of Contour, Contour TS and Contour" USB blood glucose meters are being recalled a packaging issue which, under certain conditions, can cause some test strips packaged in some small-count vials to operate outside of US FDA-cleared performance specifications and produce a low-bias reading during blood glucose testing.
VOLUME OF PRODUCT IN COMMERCE
3,617,287 vials/ 54,555,460 test strips
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Comprehensive Reverse Humeral Fracture Inserter REF 406993 Comprehensive Instrumentation Reverse Humeral Inserter Qty 1. Instrument that is attached to the trial prosthesis for placement in the prepared bone canal to check for correct sizing, version and humeral length. Also used to insert the humeral implant into the canal. a) Part numbers: 406993; and b) 406993-00. Recall # Z-3289-2011
CODE
a) Lot numbers:176070 and 657550; and b) Lot number : 203119
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by August 3, 2011. Firm initiated recall is ongoing.
REASON
Recall initiated in response to a Biomet Canada report, which noted that while testing the instruments, the pin used to secure the implant on the device did not engage on the effected lots and were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Canada, Australia, and Columbia
 
END OF ENFORCEMENT REPORT FOR OCTOBER 12, 2011
 
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