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U.S. Department of Health and Human Services

Safety

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Enforcement Report for June 15, 2011

 

June 15, 2011                                                                                        11-24
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Fresh Cucumbers. Case labeling: ***Fresh Vegetables***1 1/9 BU. ***Produce of U.S.A*** Product was shipped 1 1/9 Bushel Cartons, 24 count, 36 count Cartons. Recall # F-1381-2011
CODE
Lot # 4329 and 4314
RECALLING FIRM/MANUFACTURER
C. W. Hendrix Farms, Inc., Boca Raton, FL, by letter dated May 25, 2011. FDA initiated recall is ongoing.
REASON
C. W. Hendrix Farms, Inc. is recalling fresh cucumbers after FDA laboratory analysis detected the presence of Salmonella.
VOLUME OF PRODUCT IN COMMERCE
15,832 cartons
DISTRIBUTION
FL, GA, NC, NJ
___________________________________
PRODUCT
1) Roche Bros. Pick of the Crop Vegetable Tray***Keep Refrigerated ***Vegetable Tray 3# Ingredients: Carrots (U.S.A.) Broccoli (U.S.A.), Tomatoes (U.S.A.), Celery (U.S.A.) (See Dip Container for Dip Ingredients) 7 17524 88801 3 *** Roche Brothers 3 lb oval Vegetable Tray containing grape tomatoes, 8 oz Naturally Fresh Ranch Dip, baby carrots, celery and broccoli. UPC Code 717524888013. Recall # F-1382-2011; 
 
2) Roche Bros. Pick of the Crop***Keep Refrigerated***Veg Trio w/Dip16 oz Ingredients: Carrots (U.S.A.), Broccoli (U.S.A.) Tomatoes (U.S.A.) (See Dip Container for Dip Ingredients) 7 17524 77713 3. Roche Brothers 16 oz Veg Trio Tray containing grape tomatoes, 3 oz Naturally Fresh Ranch Dip, broccoli, and baby carrots. UPC Code 715524304162. Recall # F-1383-2011;
 
3) Del Monte***fresh***Keep Refrigerated***Veg Party Tray W/Naturally Fresh Ranch Dip Net Wt. 64 oz (1814g) ***BJ'S Veg Party Tray Ingredients: Carrots (U.S.A.), Broccoli (U.S.A.), Tomatoes (U.S.A.), Celery (U.S.A.) (See Dip Container for Dip Ingredients) Total Wt. 64 oz, UPC Code 7 17524 72513 4. Recall # F-1384-2011;
 
4) Del Monte Quality***Veg Party Tray W/Natural Fresh Ranch Vegetable Dip Ingredients: Broccoli (U.S.A.), Carrot (U.S.A.), Tomatoes (U.S.A.), Celery (U.S.A.) ***Net Wt. 3 lbs (1.361 KG) ***717524888013***Keep Refrigerated. Recall # F-1385-2011;
 
5) CIBO Express Gourmet Markets AN OTG Experience***Veggie Bowl/Dip 10 oz W/Naturally Fresh Ranch Dip Ingredients: Carrots (U.S.A.) Celery (U.S.A.), Tomatoes (U.S.A.) (See dip Container for dip ingredient). UPC Code 717524888303. Recall # F-1386-2011
CODE
1) Best If Used By: 4/23/11, 4/24/11, 4/26/11, 4/27/11, 4/28/11, 4/30//2011, 5/1/2011 and 5/3/2011. Lot #'s: 09106103, 09108103, 09110103, 09111103, 09112103, 09113103, 09115103, 09117103;
 
2) Best If Used By: 4/23/2011, 4/24/2011, 4/27/2011, 4/28/2011, 4/30/2011, 5/1/2011, and 5/3/2011. Lot #'s 09106103, 09108103, 09110103, 09111103, 09112103, 09113103, 09115103, 09117103;
 
3) Best if Used By: 4/28/2011, 4/29/2011, 4/30/2011, 5/01/2011, 5/02/2011, 5/5/2011, 5/6/2011, 5/7/2011, 5/8/2011. Lot #'s: 09106103, 09108103, 09109103, 09110103, 09111103, 09112103, 09113103, 09115103, 09116103, 09117103
 
4) Best If Used By: 4/28/11, 4/30//2011, 5/1/2011, 5/3/2011, 5/5/2011, 5/7/2011, 5/8/2011. Lot #'s: 09106103, 09109103, 09110103, 09112103, 09113103, 09116103, 09117103;
 
5) Best If Used By: 5/2/2011, Lot #: 09111103
RECALLING FIRM/MANUFACTURER
Recalling Firm: Del Monte Fresh Produce N.A., Inc., Miami, FL,by e-mail and telephone beginning May 6, 2011.
Manufacturer: Del Monte Fresh Produce N.A., Inc., Canton, MA, Firm initiated recall is ongoing.
REASON
Product may contain Salmonella.
VOLUME OF PRODUCT IN COMMERCE
969 cases (3560 trays)
DISTRIBUTION
MA, NJ, PA, DE, RI, NY, CT, NH, OH
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Mocafe Blended Ice Fruit Latte Mango Fruit Smoothie Mix is packaged and distributed in white plastic bags containing 3 pounds (1360 g) of powdered mix. The labeling depicts pictures of mango fruit and three smoothies of various colors. The label states "MAKES 35 8 oz. servings". Recall # F-1376-2011
CODE
Lot #’s: 912404, 915303, 926101, 928605, 1004601, 1011003, 1017205, 1019605, 1031604, 1103403, and 1111203
RECALLING FIRM/MANUFACTURER
Recalling Firm: Innovative Beverage Concepts, Inc., Irvine, CA, by telephone beginning May 16, 2011.
Manufacturer: Honeyville Grain Inc, Rancho Cucamonga, CA. FDA initiated recall is ongoing.
REAESON
A label review conducted by FDA investigator indicated that the labeling applied to retail units did not declare FD&C Yellow 5 Lake and FD&C Yellow 6 Lake.
VOLUME OF PRODUCT IN COMMERCE
9,513 retail units have been distributed within the last 2 years
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
GFS Medium Walnut Pieces, 1-30 lb bag, UPC 0009301585042, 25 # Salted Fancy Peanuts Packed 04/28/11 PO 14575360. Recall # F-1377-2011
CODE
Lot #: 1005-11
RECALLING FIRM/MANUFACTURER
Nut Bar Company, Inc., Grand Rapids, MI, by press release on May 26, 2011 and by telephone. Firm initiated recall is ongoing.
REASON
Peanuts were packaged into boxes labeled with labeling for walnuts and peanuts. Principle GFS label for walnuts, stamped box label states peanuts.
VOLUME OF PRODUCT IN COMMERCE
8, 25# bags
DISTRIBUTION
WI
___________________________________
PRODUCT
Pentrexcilina citricillin 500 Dietary supplement capsules with herbs; UPC codes 9196500916. Recall # F-1378-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nordimex, LLC, San Diego, CA, by letters beginning May 31, 2011.
Manufacturer: Health Advances USA, Inc., Chula Vista, CA. FDA initiated recall is ongoing.
REASON
This recall of PENTREXCILINA was initiated after an FDA inspection revealed that several products were being distributed with packaging that may have been mistakenly confused with the PENTREXYL antibiotics readily available in Mexico and possibly familiar to Hispanic consumers.
VOLUME OF PRODUCT IN COMMERCE
22,079 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Turkey Gravy -Refrigerated packaged 12 oz., 24 oz. plastic and 32 oz sealed cups. Packaged for: Stop & Shop, Giant (AHOLD), Kings Supermarket, Hannafords Brothers. Recall # F-1379-2011;
 
2) Poultry Gravy -Refrigerated packaged in 12 oz., 16 oz sealed cups. Packaged for Shaws, Hannaford Brothers Blount Fine Foods Poultry Gravy, Frozen 4 lb Product code: 99935. Recall # F1380-2011
CODE
1) Lot Number/Exp Date: 1128106F 2/6/2011 1128107F 2/6/2011 1130105F 2/8/2011 1130105F 2/8/2011 1201105F 2/9/2011 1207103F 2/16/2011 1206105D 2/15/2011 1213106F 2/21/2011 0316111 F 5/5/2011 0407112D 6/16/2011 0411117D 6/20/2011;
2) Lot Number/Exp Date: 1206105D 2/15/2011 0407112D 6/16/2011 04261113 7/5/2011 0509116D 7/18/2011; Lot Number: 1116103B
RECALLING FIRM/MANUFACTURER
Blount Seafood Corporation dba Blount Fine Foods, Fall River, MA, by telephone and email on May 26, 2011. Firm initiated recall is ongoing.
REASON
Undeclared hydrolyzed soy protein.
VOLUME OF PRODUCT IN COMMERCE
31,882 units
DISTRIBUTION
MA, ME, NJ, NY
___________________________________
PRODUCT
1) Premio brand Sliced Black Olives, Net Wt. 102 oz, (2900 g), 51 oz drained weight, packed in A/10 tin cans, Product of Egypt. Product was imported into the U.S. in 3 separate entries since September 2010: Import Entry #s: 605-1575670-2, 605-1576021-7, and 605-1576542-2. Recall # F-1387-2011;
 
2) Premio brand Medium Pitted Olives, Net Wt. 102 oz. (2900 g), 51 oz drained weight, packed in A/10 tin cans, Product of Egypt. Product was imported into the U.S. as part of 3 separate entries since September 2010: Import Entry #s: 605-1575670-2, 605-1576021-7, and 605-1576542-2. Recall # F-1388-2011
CODE
All can/lots codes distributed from September 2010 to present.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Specialty Marketing Group, Stoughton, MA, by letters dated March 25, 2011, and May 4 – 5, 2011, followed up by telephone.
Manufacturer: EMCCO for Oils and Food Industries, Cairo, Egypt. FDA initiated recall is ongoing.
REASON
Pesticide residue (chlorpyrifos) detected in excess of legal U.S. tolerance for similar product (same manufacturer/import entries; manufacture. does not have a scheduled process on file with FDA.
VOLUME OF PRODUCT IN COMMERCE
3,021 cases (6-102 oz. cans/case)
DISTRIBUTION
FL, MA, MI, NH, NJ, NY
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
TopAMAX (topiramate) tablets, 100 mg, 60 count bottles, Rx only, NDC 50458-641-65; Bottles of 60 are sold as bottles or cases of 48. Recall # D-536-2011
CODE
Lot Numbers 0KG110 Expiry Date 06-2012; 0LG222 Expiry Date 09-2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ, by press release and letters on April 14, 2011.
Manufacturer: Jansen Ortho LLC, Mamey Ward, Gurabo, PR. Firm initiated recall is ongoing.
REASON
Chemical contamination; TBA.
VOLUME OF PRODUCT IN COMMERCE
57,624 bottles
DISTRIBUTION
Nationwide
________________________________
PRODUCT
1) ExeClear-C Syrup, Antitussive / Expectorant, Sugar, Alcohol, Dye and Antihistamine Free, Each teaspoonful (5mL) syrup for oral administration contains: Codeine Phosphate, USP, 10 mg, Guaifenesin, USP, 200mg, Rx Only, 16 fl. oz. (473 mL), NDC 68047-222-16. Recall #D-543-2011;
 
2) ExeClear-DM Syrup, Antitussive / Decongestant, Sugar Free - Alcohol Free. Each teaspoonful (5mL) syrup for oral administration contains: Dextromethorphan Hydrobromide, USP, 15 mg, Pseudoephedrine Hydrochloride, USP, 30 mg, Guaifenesin, USP, 150 mg, Rx Only, 16 fl. oz. (473 mL), NDC 68047-223-16. Recall #D-544-2011;
 
3) ENDACOF-PD, Pediatric Drops, Antihistamine / Antitussive/ Decongestant, Each dropperful (1 mL) for oral administration contains: Brompheniramine Maleate 1 mg, Dextromethorphan HBr, 3 mg, Pseudoephedrine Hydrochloride 12.5 mg, Rx only, 1 fl. oz., (30 mL), NDC 68047-010-30. Recall #D-545-2011;
 
4) LOHIST-PD, Pediatric Drops, Antihistamine / Decongestant, Each dropperful (1 mL) for oral administration contains: Brompheniramine Maleate 1.0 mg, Pseudoephedrine Hydrochloride, 12.5 mg, Rx only, 1 fl. oz., (30 mL), NDC 68047-011-30. Recall # D-546-2011;
 
5) NOHIST-PDX DROPS, Antitussive - Antihistamine - Nasal Decongestant, Each dropperful (1 mL) contains: Dextromethorphan HBr, 2.75 mg, Chlorpheniramine Maleate 0.75 mg, Phenylephrine HCl, 1.75 mg, Rx Only, 1 fl. oz. (30 mL), NDC 68047-0115-30. Recall # D-547-2011;
 
6) LOHIST-D, Antihistamine, Nasal Decongestant, Sugar Free - Alcohol Free - Dye Free, Chlorpheniramine Maleate, USP 2 mg, Pseudoephedrine HCl, USP, 30 mg in each 5 mL (1 teaspoonful), 16 fl. oz. (473 mL), NDC 68047-120-16. Recall # D-548-2011;
 
7) ENDACOF-C Liquid, Antitussive / Decongestant, Sugar Free - Alcohol Free - Dye Free. Each teaspoonful (5mL) contains: Codeine Phosphate, 10 mg, Chlorpheniramine Maleate 2 mg, Rx Only, 16 fl.oz. (473 mL), NDC 68047-145-16. Recall # D-549-2011;
 
8) ENDACOF-DC Liquid, Antitussive / Decongestant, Sugar Free - Alcohol Free - Dye Free. Each teaspoonful (5mL) contains: Codeine Phosphate, 10 mg, Pseudoephedrine Hydrochloride, 30 mg, Rx Only, 16 fl. oz. (473 mL), NDC 68047-146-16. Recall # D-550-2011;
 
9) ENDACOF-DC Liquid, Antitussive / Decongestant, Sugar Free - Alcohol Free - Dye Free - Gluten Free, Each 5 mL (1 teaspoonful) for oral administration contains: Codeine Phosphate, 10 mg, Pseudoephedrine Hydrochloride, 30 mg, Rx Only, Net Contents: 16 fl. oz. (473 mL), NDC 68047-148-16. Recall # D-551-2011;
 
10) ENDACOF - DH Liquid, Antitussive / Decongestant / Antihistamine, Sugar Free - Alcohol Free - Dye Free, Each teaspoonful (5mL) contains: Phenylephrine HCl, 7.5 mg, Brompheniramine Maleate, 4 mg, Dihydrocodone Bitratrate, Rx only, 3 mg, 16 fl.oz. (473 mL), NDC 68047-139-16. Recall # D-552-2011
CODE
1) Lot Number: 10010;
2) Lot Numbers: 09081, 09086, and 09098;
3) Lot Numbers: 09050, 09056, 09090, and 09103;
4) Lot Numbers: 09085 and 09099;
5) Lot Numbers: 09034, 09035, and 09036;
6) Lot Numbers: 09014, 09055, 09082, 09087, 10011, and 10013;
7) Lot Numbers: 09046, 09047, 09048, 10007, 10008, and 10009;
8) Lot Numbers: 09057, 09058, 09059, 09094, and 09095;
9) Lot Numbers: 10025 and 10026;
10) Lot Numbers: 09068, 09069, 09070, and 09104
RECALLING FIRM/MANUFACTURER
Recalling Firm: Larken Laboratories, Inc., Canton, MS, by letter on March 14, 2011.
Manufacturer: Deltex Pharmaceuticals, Inc., Rosenberg, TX. FDA initiated recall is ongoing.
REASON
cGMP Deviations; The manufacturer failed to obtain required FDA approval for its prescription drug products, failed to comply with FDA regulations governing OTC drug products, and failed to comply with current good manufacturing practice requirements.
VOLUME OF PRODUCT IN COMMERCE
79,216 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Tretinoin Capsules, 10 mg, 100-count bottle, Rx only; NDC 0555-0808-02. Recall # D-554-2011
CODE
Lot # 702305, Exp 08/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on May 10, 2011.
Manufacturer: Barr Laboratories Inc., Pomona, NY. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: May not conform to impurity specifications.
VOLUME OF PRODUCT IN COMMERCE
1,880 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
CLONAZEPAM Tablets USP, 2 mg, Rx only, 100 count bottle, NDC 0093-0834-01. Recall # D-555-2011
CODE
Lot # 28C004, Exp 5/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on April 20, 2011.
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
Low Tablet Weight: Tablets may not conform to weight specifications.
VOLUME OF PRODUCT IN COMMERCE
28,033 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
PLAVIX (clopidogrel bisulfate) Tablets, 75 mg, 30 count bottles, NDC 63653-1171-6. Recall # D-557-2011
CODE
Lot 0F61121 Exp Jun 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bristol-Myers Squibb Co., New Brunswick, NJ, by letters on March 1, 2011. 
Manufacturer: Bristol Myers Squibb Manufacturing Co., Humacao, PR. Firm initiated recall is ongoing.
REASON
Chemical contamination; presences of 2,4,6-tribromoanisole (TBA).
VOLUME OF PRODUCT IN COMMERCE
105,576 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Glyburide and Metformin Hydrochloride,Tablets USP, 2.5 mg/500 mg, 100-count bottle, Rx only, NDC 0093-5711-01. Recall # D-558-2011;
 
2) Glyburide and Metformin Hydrochloride, Tablets USP, 5 mg/500 mg, a) 100-count bottle (NDC 0093-5712-01), b)500-count bottle (NDC 0093-5712-05), Rx only. Recall # D-559-2011
CODE
1) Lot # G31120, Exp 2/2011;
 
2) Lot a) 16G319, 16G321, Exp 7/2011; b) 16G275, 16G276, 16G277, Exp 3/2011; 16G330, 16G346, 16G347, and 16G348, Exp 8/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, letters on February 23, 2011 
Manufacturer: Teva Pharmaceutical Industries, Har Hozvim, Jerusalem, Israel. FDA initiated recall is ongoing.
REASON
CGMP Deviations: Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".
VOLUME OF PRODUCT IN COMMERCE
52,016 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Alendronate Sodium Tablets, USP 10 mg, 30 count bottles, Rx only. NDC 41616-636-83. Recall # D-560-2011
CODE
Batch No JKJ2441A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI, by letter on December 16, 2010.
Manufacturer: Sun Pharmaceuticals Ltd. (prev. MJ Pharmaceuticals Ltd.), Halol, Gujarat State (Baroda), India. Firm initiated recall is ongoing.
REASON
Labeling: Label Error on Declared Strength: Bottle labeled as Alendronate Sodium Tablets 10 mg was filled with Alendronate Sodium 5 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
4,651 bottles
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
1) Azithromycin Tablets, 250 mg, 6 x 1 blister packs, Rx only, NDC 0093-7146-18. Recall # D-563-2011;
2) Azithromycin Tablets, 500 mg, 30 count bottle, Rx only, NDC 0093-7169-56. Recall # D-564-2011
CODE
1) Lot #01A173;
2) Lot #02A016
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on February 23, 2011.
Manufacturer: Teva Pharmaceutical Industries, Har Hozvim, Jerusalem, Israel. FDA initiated recall is ongoing.
REASON
CGMP Deviations: Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".
VOLUME OF PRODUCT IN COMMERCE
125,413 blisters and bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Calan SR (verapamil hydrochloride) SUSTAINED-RELEASE Caplets, 120 mg 100 count bottle, Rx only, NDC 0025-1901-31. Recall # D-566-2011
CODE
Lot # C100010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ranbaxy Pharmaceuticals, Inc., Princeton, NJ, by e-mail beginning March 11, 2011.
Manufacturer: Pfizer Pharmaceuticals LLC, Caguas, PR. Firm initiated recall is ongoing.
REASON
Marketed Without an Approved NDA/ANDA: The recall is being initiated because the Pfizer manufacturing site in Caguas, PR is currently not an approved site for manufacturing Calan SR 120mg.
VOLUME OF PRODUCT IN COMMERCE
4,927 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Innohep (tinzaparin sodium injection) 2 mL multi-dose vial; 20,000 IU/mL, Rx only, NDC 67211-342-53, Rx only. Made in Denmark. Recall # D-568-2011
CODE
Lot Number Expiration Date amounts distributed 10 x 2 ml vials DC3957 2-2011 10190 DC5102 2-2011 10, 930 DC6685 3-2011 11320 DC7549 4-2011 11910 DC7118 4-2011 10990 DC8258 5-2011 11550 DC7550 5-2011 10750 DC9390 7-2011 10940 DC9391 7-2011 10520 DC9651 7-2011 10650 DD0713 9-2011 10320 DC5102 2-2011 10930 lot number exp dates amts distributed 1 X 2 ml vial DC3381 2-2011 10804 DC6985 4-2011 10527 DC8228 5-2011 10330 DC9158 7-2011 10015 DC9874 7-2011 9091 DC9873 8-2011 0
RECALLING FIRM/MANUFACTURER
Celgene Corp., Basking Ridge, NJ, by letter on February 15, 2011. Firm initiated recall is ongoing.
REASON
Presence of particulate matter: Theoretical risk of presence of particulate matter (glass, metal, wood).
VOLUME OF PRODUCT IN COMMERCE
181,767 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Amoxicillin for Oral Suspension, USP, 125mg/5mL, 80mL bottles, Rx only, NDC 0093-4150-79. Recall # D-572-2011
CODE
Lot # 35412445A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on June 3, 2011.
Manufacturer: Novopharm Ltd., Scarborough Ontario, Canada. Firm initiated recall is ongoing.
REASON
Product lacks stability (out-of-specification assay result for potency during stability testing).
VOLUME OF PRODUCT IN COMMERCE
18,574 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Hemorrhoidal Suppositories, Phenylephrine HCl 0.25%, compare to the active ingredients in Preparation H(Registered Trademark) Suppositories. Sold under the following brand names: 1) CVS pharmacy 24 suppositories, UPC 50428-21327 and 48 suppositories, UPC 50428-04806; 2) duane reade, 24 suppositories, UPC 39194-00354; 3. exact, 12 suppositories, UPC 60383-82499 and 24 suppositories, UPC 60383-82500, Product of U.S.A.; 4) Fred's 12 suppositories UPC 84579-18718; 5) HealthCare 6 suppositories, UPC 92215-50126; 6) health PRIDE 12 suppositories, UPC 41310-62210; 7) Life 12 suppositories, UPC 57800-06648 and 24 suppositories UPC 57800-06649; 8) Live Better 12 suppositories UPC 41310-62028; 9) Medic, 12 suppositories UPC 21140-74325; 10) Personnelle 12 suppositories UPC 55989-06006, and 24 suppositories UPC 55989-06005; 11) Premier Value12 suppositories UPC 40986-01332, 24 suppositories UPC 40986-01333; 12) Quality Choice 12 suppositories UPC 35515-90549, NDC 63868-208-12. 24 suppositories UPC 35515-94644, NDC 63868-208-24. Made in U.S.A; 13) Rite Aid Pharmacy 12 suppositories UPC 11822-00129, 24 suppositories UPC 11822-00131, 48 suppositories UPC 11822-06507; 14) Target 12 suppositories UPC 50730-00605, NDC 11673-394-53. Made in USA; 15) up & up 12 suppositories, UPC 50730-00605, NDC 11673-394-53; 16) Walgreens 12 suppositories UPC 11917-07028, 24 suppositories UPC 11917-07026, 48 suppositories UPC 11917-07027; 17) Western Family 12 suppositories UPC 15400-03494. Recall # D-537-2011
CODE
Lot numbers beginning with the digits 8D - 8M, 9A - 9M, 0A - 0M, and 1A - 1C
RECALLING FIRM/MANUFACTURER
H & P Industries, Inc., Hartland, WI, by letter, dated April 28, 2011. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient) Drug: Product is being recalled due to sub-potency. Six months stability result was below specification for the active ingredient, Phenylephrine.
VOLUME OF PRODUCT IN COMMERCE
46,478 cases
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
1) Enjuvia(TM) (synthetic conjugated estrogens, B) Tablets, 0.3 mg, NDC 51285-406-75 (7 count bottle) and NDC 51285-406-02 (100 count bottle). Recall # D-538-2011;
 
2) Enjuvia(TM) (synthetic conjugated estrogens, B) Tablets, 0.45 mg, NDC 51285-407-75 (7 count bottle), NDC 51285-407-02 (100 count bottle). Recall # D-539-2011;
 
3) Enjuvia(TM) (synthetic conjugated estrogens, B) Tablets, 0.625 mg, NDC 51285-408-75 (7 count bottle), NDC 51285-408-02 (100 count bottle). Recall # D-540-2011;
 
4) Enjuvia(TM) (synthetic conjugated estrogens, B) Tablets, 0.9 mg, NDC 51285-409-75 (7 count bottle), NDC 51285-409-02 (100 count bottle). Recall # D-541-2011;
 
5) Enjuvia(TM) (synthetic conjugated estrogens, B) Tablets, 1.25 mg, NDC 51285-410-75 (7 count bottle), NDC 51285-410-02 (100 count bottle). Recall # D-542-2011
CODE
1) Lot numbers 316107 (7 count bottle) and 316108 (100 count bottle), Exp 8/2011
2) Lot numbers 312875 (7 count bottle), 312876 and 313245 (100 count bottle), Exp 8/2011;
3) Lot numbers 312513 (7 count bottle) and 312822 (100 count bottle), Exp 6/2011;
4) Lot numbers 312521 (7 count bottle) and 312823 (100 count bottle), Exp 7/2011;
5) Lot numbers 702956 (7 count bottle) and 702618 (100 count bottle), Exp 8/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on March 30, 2011.
Manufacturer: Teva Women's Health Inc., Cincinnati, OH. Firm initiated recall is ongoing.
REASON
Subpotent assay results; OOS result for sodium estrone sulfate (ESTS) was reported at the 18 months stability timepoint.
VOLUME OF PRODUCT IN COMMERCE
201,871 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Xeloda (capecitabine) Tablets, each tablet contains 500 mg, Rx only, 120-count bottles, NDC 0004-1101-50. Recall # D-553-2011
CODE
Lot number: U9452, EXP DATE 9/2012 X0054, EXP DATE 5/2013 X0071, EXP DATE 5/2013 X0073, EXP DATE 5/2013 X0078, EXP DATE 7/2013 X0079 EXP DATE 7/2013 X0080 EXP DATE 7/2013 X0084 EXP DATE 8/2013 X0085 EXP DATE 8/2013 X0086 EXP DATE 8/2013 X0087 EXP DATE 8/2013 X0093 EXP DATE 8/2013 X0094 EXP DATE 8/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hoffmann La Roche Inc., Nutley, NJ, by letters on March 21, 2011.
Manufacturer: S.A. de C.V., Toluca , Mexico. Firm initiated recall is ongoing.
REASON
Chemical contamination; presence of low levels of naphthalene and/or 1,4 dichlorobenzene causing an off odor.
VOLUME OF PRODUCT IN COMMERCE
74,449 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Diflorasone Diacetate Ointment USP, 0.05% Rx only, a) 15 g tube (NDC 51672-1295-1) and b) 60 g tube (NDC 51672-1295-3), TARO label. Recall # D-556-2011
CODE
a) Lots K9052 and b) K9053; expiration date 11/2011 for both lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, by letters dated March 4, 2011.
Manufacturer: Taro Pharmaceuticals, Inc., Brampton Ontario, Canada. Firm initiated recall is ongoing.
REASON
Impurities/degradation products: The product had out-of-specification results for a known degradant and total degradants observed at 14-month interval.
VOLUME OF PRODUCT IN COMMERCE
a) 9,360 tubes; b) 5,808 tubes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Nadolol and Bendroflumethiazide Tablets, USP, 40/5 mg, Rx only, 100 count bottles, NDC # 0115-5311-01. Recall # D-561-2011;
 
2) Global Nadolol and Bendroflumethiazide Tablets, USP, 80/5 mg, Rx only, 100 count bottles, NDC # 0115-5322-01. Recall # D-562-2011
CODE
1) Lot codes: 9040181, Exp 4/30/2011; H9071121, Exp 8/31/2011; H9121631, Exp 1/31/2012;
2) Lot codes: H9090981, Exp 8/31/2011; H9090991, Exp 8/31/2011
RECALLING FIRM/MANUFACTURER
Impax Laboratories, Hayward, CA, by letters on March 14, 2011. FDA initiated recall is ongoing. 
REASON
Lots of drug product were made using Mannitol powder, not granular grade that is listed in FDA application.
VOLUME OF PRODUCT IN COMMERCE
6268 bottles of 40/5 mg; 1649 bottles of 80/5 mg.
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Antabuse (Disulfiram Tablets, USP), 500 mg, 100-count bottle, Rx only; NDC 51285-524-02, UPC 3 51285 52402 7. Recall # D-565-2011
CODE
Lot #317171, Exp 9/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on April 1, 2011.
Manufacturer: Pliva Krakow S.A., Krakow, Poland. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient) Drug: Some tablets may not conform to weight specifications and have the potential to be Subpotent.
VOLUME OF PRODUCT IN COMMERCE
1,240 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Adagen (pegademase bovine) injection, 250 units/mL, 1.5 mL single-dose vials, Four 1.5 mL single-dose vials per carton, Rx Only, NDC 57665-001-01. Recall # D-567-2011
CODE
Lot #0017A, Exp 08/MAR/2011; Lot #0018A Exp 02/MAY/2011; and Lot #0019A, Exp 11/MAY/2011.
RECALLING FIRM/MANUFACTURER
Sigma-Tau Pharmasource, Inc., Indianapolis, IN, by letters on January 7, 2011; February 24, 2011, and March 14, 2011. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Levels of Impurity A may rise above the specification limits of <2.0%.
VOLUME OF PRODUCT IN COMMERCE
3,188 vials
DISTRIBUTION
Nationwide, France, Australia, and Japan
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1370-11
CODE
Units: LG23650, LG23651, GF42284, LG40565
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on April 27, 2005. Firm initiated recall is complete.
REASON
Blood products, labeled as leukoreduced without the assurance they met the requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1401-11
CODE
Unit: 2418331
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by facsimile on November 8, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1411-11
CODE
Unit: 3735801
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Lancaster County Medical Society, Lincoln, NB, by fax on March 11, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from an emigree from a malarial endemic area who revisited the area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1414-11
CODE
Unit: W043210079933
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by fax on April 25, 2011. 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
IN, TN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Recall # B-1416-11
CODE
Units: 8032287; 8032287
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by telephone on April 27, 2007. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1423-11
CODE
Unit: LV19233
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by telephone on January 17, 2007 and by letter dated January 29, 2007. Firm initiated recall is complete.
REASON
Blood product, labeled as leukoreduced but did not meet the requirements for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1425-11
CODE
Unit: LV49038
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by letter on January 28, 2008, March 5, 2008. 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
1 unit
DISTRIBUTION
CA, FL
___________________________________
PRODUCT
Cornea. Recall # B-1426-11
CODE
Units: OSI016810, 0SI017310, OSI017410, OSI017510, OSI017610, OSI017710, OSI017810, OSI018110, OSI018210, OSI018310, OSI018410, OSI018510, OSI018910, OSI020010, OSI020110, OSI020210, OSI020310, OSI020910, OSI021210, OSI021310, OSI021410, OSI021710, OSI021810, OSI021910, OSI022010, OSI022210, OSI022310, OSI022410, OSI022510, OSI022710, OSI022910, OSI023210, OSI023310, OSI023610, OSI023710, OSI023810, OSI023910, OSI024010, OSI024110, OSI024210, OSI024310, OSI024410, OSI024510, OSI024910, OSI025010, OSI025310, OSI026110, OSI026210, OSI026310, OSI026410, OSI026510, OSI026610, OSI026710, OSI026810, OSI027110, OSI027210, OSI027310, OSI027410
RECALLING FIRM/MANUFACTURER
Ocular Systems, Inc., Piedmont Triad Research Park, Winston Salem, NC, by telephone on February 24 and 25, 2010 and by letter on March 4, 2010. Firm initiated recall is complete.
REASON
Human Corneal Tissue, processed outside of the firm's standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
58 tissues
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Source Plasma. Recall # B-1432-11
CODE
Units: 0180267370; 0180267855; 0180268587; 0180269072; 0180309369; 0180309605; 0180310538; 0180310911; 0180311371; 0180311758; 0180312782; 0180313140; 0180313735; 0180314114
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Las Vegas, NV, by letter dated February 23, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for testing positive for hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 Units
DISTRIBUTION
CA, Spain
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1433-11
CODE
Unit: 1675867
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, HI, by fax on October 2, 2008. 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
HI
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1434-11
CODE
Unit: W020007103299
RECALLING FIRM/MANUFACTURER
National Naval Medical Center Bb, Bethesda, MD, by facsimile dated March 26, 2007. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall #B-1435-11
CODE
Unit: LV16868
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by letter dated December 18, 2006. 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
1) Red Blood Cells. Recall # B-1436-11;
2) Platelets. Recall # B-1437-11
CODE
1), 2) Units: 1149879
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, HI, by letter dated June 6, 2007. 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
HI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1446-11
CODE
Units: W090708013366, W090708002144, KR95888, KR79355
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by facsimile on December 19, 2008 or December 31, 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
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1451-11
CODE
Units: LE99693, LE99694, LE99695, LE99696, LE99698, LE99699, LE99600, LE99701, LE99702, LE99703, LE99704, LE99705, LE99706, LE99707, LE99709, LE99710, LE99711, LE99712, LE99714, LE99715, LE99716, LE99717, LE99718, LE99720, LE99722, LE99724, LE99725, LE99726, LE99733
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone and fax on April 20, 2005. Firm initiated recall is complete.
REASON
Blood products, labeled as leukoreduced without the assurance they met the requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1459-11;
2) Plasma Frozen within 24 hours (FP24). Recall # B-1460-11
CODE
1) Unit: W038111082133;
2) Unit: W038111009616  
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on April 7, 2011 and by letter on April 14, 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
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis. Recall # B-1461-11
CODE
Unit: W120611003147
RECALLING FIRM/MANUFACTURER
Michigan Blood, Grand Rapids, MI, by telephone on March 15, 2011. Firm initiated recall is complete.
REAESON
Blood product, which did not meet the acceptable product specification, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1463-11
CODE
Unit: 20KV21684
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by facsimile and letter on March 31, 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
UT
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1488-11
CODE
Units: W115908050740; 2594380; 3535829; 3533786
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by facsimile on July 29, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1489-11 
CODE
Units: W115908051218; 2594741; 2592986
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by facsimile on September 2, 2008 and September 26, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1490-11
CODE
Unit: W115908082146
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by facsimile on October 3, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1392-11
CODE
Units: 12GH67548; 12GH67587; 12GH67534; 12GH67596; 12GH67613
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on February 4, 2011 and by letter on February 8, 2011.  
Manufacturer: American Red Cross Blood Services, Wilmington, NC. Firm initiated recall is complete.
REASON
Blood products, for which the quality control testing was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1415-11
CODE
Unit: W043210079933
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by fax on April 25, 2011. 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
IN, TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1418-11
CODE
Units: 041GE93654, 041GE93641, 041GE93643, 041GE93633, 041GE93634, 041GE93646, 041GE93649, 041GE93655, 041GE93635, 041GE93636, 041GE93640, 041GE93644, 041GE93651, 041GE93652
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by telephone on September 19, 2007 and follow up letter on October 5, 2007. Firm initiated recall is complete.
REASON
Blood products, exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1421-11
CODE
Units: KR96399; KR80541
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by facsimile on April 29, 2008. Firm initiated recall is complete.
REAESON
Blood products, collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1422-11 
CODE
Unit: 2689395
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by letter dated September 1, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose temperature was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1430-11
CODE
Recall # V74939
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, via e-mail on May 22, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from donors whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1453-11
CODE
Units: LG54214, LG49635
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on May 22, 2005. Firm initiated recall is complete.
REASON
Blood products, documented as being out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
1) Philips Microstream� Model M1923A FILTERLINE H SET INF/NEO 25UN PHILIPS These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They provide a means to transport samples of patient respiratory gases from the patient's airway to the Microstream capnograph. This is performed by placing the airway adapter portion of the FilterLine H Set Infant/Neonate an VitaLine H Set Infant/Neonatal in the patient airway system of a respirator or an anesthesia machine. Manufactured from October 2010 through February 2011. The M1923A Filterline H Set is also shipped as part of the M3015A Measurement Server Extension, Product Option #K33. Recall # Z-2247-2011;
 
2) Philips Microstream� Model 989803159581 VITALINE H SET INFANT/NEONATAL 25 UN PHILIPS. These products are used with Philips Monitors for the measurement of endtidal CO2 in infants and neonates. They provide a means to transport samples of patient respiratory gases from the patient's airway to the Microstream capnograph. This is performed by placing the airway adapter portion of the FilterLine H Set Infant/Neonate an VitaLine H Set Infant/Neonatal in the patient airway system of a respirator or an anesthesia machine. Manufactured from October 2010 through February 2011. Recall # Z-2248-2011
CODE
1) Lot Codes: M8330M10 M8386N10 M8411P10 M8451P10 M8477A11 M8514A11 M8572B11
2) Lot Code: M8409P10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated April 2011.
Manufacturers: Philips Medizin Systeme Boblingen Gmbh, Boblingen, Germany;
Oridion Medical 1987 Ltd., Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
Fine plastic strands on inner surface of the infant/ neonatal airway adapter may become dislodged and inhaled by the patient.
VOLUME OF PRODUCT IN COMMERCE
1,025 units
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1)  Abbott CELL-DYN 3700 Hematology Analyzer CS (Closed Sampler), and CELL-DYN 3700 SL (Sample Loader), Medical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories. 3700CS, list numbers: 02H30-01, 02H30-03; 3700SL, list numbers: 02H31-01, 02H31-03. Recall # Z-1701-2011;
 
2) Abbott CELL-DYN 3200 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3200 SL (Sample Loader). Medical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories. 3200CS list numbers: 04H59-01, 04H59-03; 3200SL, list numbers: 04H60-01, 04H60-03. Recall # Z-1702-2011
 
3) Abbott CELL-DYN 3500 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3500 SL (Sample Loader). Medical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories. List numbers: 3500CS: 91340-01, 91340-03; 3500SL: 91350-01, 91350-03. Recall # Z-1703-2011;
 
4) Abbott CELL-DYN 3000CS (Closed Sampler), CELL-DYN 3000SL (Sample Loader). Medical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories. List numbers: 91323-01, 91313-03 (3000CS) and List numbers 91325-01, 91325-03 (3000SL). Recall # Z-1902-2011
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letters, dated March 22, 2011. Firm initiated recall is complete.
REASON
FIRE HAZARD-- Some power supply modules may have incorrect fuses installed, which may result in fires and smoking.
VOLUME OF PRODUCT IN COMMERCE
2219 CELL-DYN 3200; 2961 CELL-DYN 3500 and 3700; CELL-DYN 3000 - 306 currently still in use.
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Toshiba Infinix-i, INFX-8000C. The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Recall # Z-1871-2011;
 
2) Toshiba Infinix-i, INFX-8000F. The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Recall # Z-1872-2011;
 
3) Toshiba Infinix-i, INFX-8000V. The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Recall # Z-1873-2011;
 
4) Toshiba Infinix-i, DFP-8000D. The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Recall # Z-1874-2011
CODE
Software version 4.23
RECALLING FIRM/MANUFACTURER
Toshiba American Medical Systems Inc., Tustin, CA, by letter beginning December 21, 2010. Firm initiated recall is ongoing.
REASON
Under some conditions during high doses procedures the cumulative air kerma display may reach its maximum capability and fail to display the accrued value.
VOLUME OF PRODUCT IN COMMERCE
220 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia. Recall # Z-2022-2011
CODE
Lot # C10247 boxes 0532 through 0593
RECALLING FIRM/MANUFACTURER
Abbott Point of Care, Nepean Ontario, Canada, by letter dated February 2011. Firm initiated recall is ongoing.
REASON
i-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit.
VOLUME OF PRODUCT IN COMMERCE
6,575 cartridges
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Hospira Latex-Free Blood Secondary Set, 26 Inch with Secure Lock; a sterile Rx tubing set for the administration of fluids from a blood bag in series with an I.V. solution bottle and I.V. set; List No. 4602-58 For the administration of fluids from a blood bag in series with an I.V. solution bottle and I.V. set. Recall # Z-2024-2011;
 
2) Hospira LifeShield Latex-Free HEMA Y-Type Blood Set, Nonvented, 100 Inch with Clave and Secure Lock; a sterile Rx tubing set for the alternate administration of fluids from a blood bag and I.V. solution container; List No. 12450-48 For the alternate administration of fluids from a blood bag and I.V. solution container. Recall # Z-2025-2011;
 
3) Hospira LifeShield Latex-Free HEMA Y-Type Blood Set, Nonvented, 99 Inch with Drip Chamber Pump, 210 Micron Filter, Prepierced Injection Site and Secure Lock; a sterile Rx tubing set for the alternate administration of fluids from a blood bag and I.V. solution container; List No. 12698-65 For the alternate administration of fluids from a blood bag and I.V. solution container. Recall # Z-2026-2011;
 
4) Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110 Inch, Non-DEHP; a sterile Rx tubing set for epidural administration of fluids with the Gemstar Pump; List No. 13744-28 For epidural administration of fluids with the Gemstar Pump. Recall # Z-2027-2011
CODE
1) Lot 940405H;
2) Lots 930875H and 940445H;
3) Lot 942905H;
4) Lots 930345H, 931425H, 932785H
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira, Inc., Lake Forest, IL, by letter dated March 28, 2011.
Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.
REASON
There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing.
VOLUME OF PRODUCT IN COMMERCE
147,646 sets
DISTRIBUTION
Nationwide, Canada, Korea, Singapore
___________________________________
PRODUCT
1) Codman Disposable Twist Drill Product code: 80-1200. This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures. Recall # Z-2028-2011;
 
2) Ghajar Guide Ventriculostomy Kit Product Code: 80-1185 This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures. Recall # Z-2029-2011;
 
3) Codman Metal Disposable ICP Kit Product Code: 80-1190. This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures. Recall # Z-2030-2011;
 
4) Codman Plastic Disposable ICP Kit, Adult Product Code: 80-1196. This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures. Recall # Z-2031-2011;
 
5) Codman Cranial Hand Drill Product Code: 82-6607. This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures. Recall # Z-2032-2011;
 
6) Codman Plastic Disposable ICP Kit, Complete, Adult Product Code 80-1197. This is a single use, disposable drill kit designed for gaining access to the cranium for therapeutic and/or diagnostic procedures. Recall # Z-2033-2011
CODE
1) Lot Codes: JA292; KA243; LA259; AB273; LB308; AC267; CB286; EB229; EB356 ; EB327; JB306; LB308; 422004; 422005; 422006; 429017; 430536;
 
2) Lot Codes: 421302 424870 424871 SW10-3731 430880 427693 429015 430532 434231 MA216 BB235 BB317 DB214 EB338 GB263 JB240 KB216 MB219;
 
3) Lot Codes: 421298 422002 SW103730 444161 KA291 AB243 DB319 FB302 JB212;
 
4) Lot Codes: 404206 426891 KA209 MB270;
 
5) Lot Codes: 429084 429085 429086 430880 430881 430882 430883 430884 430885 430886 434297 434298 434299 JA272 JA296 JA238 KA230 KA265 LA212 LA247 LA279 MA215 MA254 MA299 AB207 AB288 AB289 BB312 CB250 DB203 DB204 DB207 EB328 EB329 EB343 EB344 FB232 422690 422691 422692 422693 422694 422695 422696 422697 422698 422699 422700 425478 424537 429080 429081 429082 429083 FB238 FB345 GB204 GB205 GB206 GB287 HB201 HB202 HB280 JB200 JB288 KB210 KB276 KB277 LB253 LB303 LB304 MB255;
 
6) Lot code LA216
RECALLING FIRM/MANUFACTURER
Codman & Shurtleff, Inc., Raynham, MA, by letters dated November 30, 2010 and January 31, 2011. Firm initiated recall is ongoing.
REASON
Packaging defect may compromise sterility of device.
VOLUME OF PRODUCT IN COMMERCE
14,792 units
DISTRIBUTION
AL, FL,GA, KY, MA, MI, MN, MS, OR, PA, RI, UT,WI, WV, and Argentina, Australia, Canada, Bahamas , Belgium, Dubai, Japan, Madrid, Mexico, New Zealand, Saudia Arabia, UAE, Uruguay, and United Kingdom
___________________________________
PRODUCT
1) **REF MCA5-1SB*** 1 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA). ***ANSPACH***Sterile. Sterilized using Irradiation***Rx Only.***Made in the USA. Intended usage: Cutting and shaping bone including bones of the spine and cranium. Recall # Z-2034-2011;
 
2) ***REF MCA5-15SB ***1.5 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only*** Made in the USA. Intended usage: Cutting and shaping bone including bones of the spine and cranium. Recall # Z-2035-2011;
 
3) ***REF MCA5-2SB*** 2 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA). ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only*** Made in the USA. Intended usage: Cutting and shaping bone including bones of the spine and cranium. Recall # Z-2036-2011;
 
4) ***REF MCA7-15SB*** 1.5 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only*** Made in the USA. Intended usage: Cutting and shaping bone including bones of the spine and cranium. Recall # Z-2037-2011;
 
5) ***REF MCA7-1SB*** 1 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA). ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA. Intended usage: Cutting and shaping bone including bones of the spine and cranium. Recall # Z-2038-2011;
 
6) ***REF MCA7-2SB***2 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA). ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA. Intended usage: Cutting and shaping bone including bones of the spine and cranium. Recall # Z-2039-2011
CODE
1) Lot numbers: C523029650, D063031863, D113032935, D113032971, D163034223, and D173034360;
2) Lot numbers: C523029660, D063031862, D093032542, D113032933, D113032970, D173033269, and D223034370;
3) Lot numbers: C523029666, D063031864, D113032937, D113032974, D163033908, D253036524, and D353039102;
4) Lot numbers: D063031866, C523029663, D093032540, D113032924, D113032979, D123033073, and D223034655;
5) Lot numbers: C523029652, D063031867, D113032925, D173034373 and D213035424;
6) Lot numbers: C523029789, D113032927, D333038386, D113032982, D093032541 and D243033308
RECALLING FIRM/MANUFACTURER
Anspach Effort, Inc. Palm Beach Gardens, FL, by letter dated October 6, 2010. Firm initiated recall is ongoing.
REASON
Anspach Effort, Inc. is recalling their Sterile Bone Cutting Burs that was manufactured with incomplete flutes which could cause degraded cutting performance and in some cases not cut at all. Anspach has not received any complaints related to this problem.
VOLUME OF PRODUCT IN COMMERCE
271 units
DISTRIBUTION
AZ, CA, FL, GA, IL, IN, LA, MA, MI, Australia, Belgium, England, France, Italy, Japan, South Africa, Spain and Sweden
___________________________________
PRODUCT
Boston Scientific's LATITUDE Patient Management System: LATITUDE 6.1 Patient Management System Website Server software, Model 6488 for United States Server software, Model 6465 for European Union LATITUDE 6.2 Patient Management System Website Server software, Model 6441 for Canada Server software, Model 6442 for Australia / New Zealand Intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database. Recall # Z-2052-2011
CODE
Software Versions 6.x versions launched on June 6, 2010 or later.
RECALLING FIRM/MANUFACTURER
Boston Scientific CRM Corp., Saint Paul, MN, by letter dated January 2011. Firm imitated recall is ongoing.
REASON
Boston Scientific has determined that data within certain printed reports obtained from the LATITUDE Patient Management System may not be accurate, in that, the Most Recent Presenting Electrogram (MRP-EGM) for some of the selected patients may be either missing or incorrect.
VOLUME OF PRODUCT IN COMMERCE
25,836 units
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
___________________________________
PRODUCT
1) PetPride Complete Nutrition Formula Cat Food Net Wt 3.5 lb UPC 1111088128 & 18 lb bags UPC 1111071357. Recall # V-162-2011;
 
2) PetPride Tasty Blend Poultry & Seafood Flavors Cat Food Net Wt 3.5 lb bag, UPC 1111088152 & 18 lb bag, UPC 1111074580. Recall # V-163-2011;
 
3) Kroger Value Nutritionally Complete Cat Food For Kittens & Adult Cats Net Wt 3 lb bag UPC 1111000018. Recall # V-164-2011;
 
4) Kroger Value Chunk Style Dog Food Complete & Balanced for All Dog Sizes Net Wt 18 lb bag, UPC 1111071559 & 50 lb bag UPC 1111000108. Recall # V-165-2011;
 
5) Disney's Old Yeller Chunk Style Dog Food 100% Complete & Balanced for All Dog Sizes Net Wt. 22 lb bag UPC 1111074566 50 lb bag UPC 1111074563. Recall # V-166-2011;
 
6) PetPride Kitten Complete Nutrition Formula Cat Food Net Wt. 3.5 lb bag UPC 1111071903. Recall # V-167-2011
CODE
1) Sell by dates of OCT 23 11 DP & OCT 24 11 DP;
2) Sell By Dates of OCT 23 11 DP & OCT 24 11 DP;
3) Sell By Date OCT 23 11 DP & OCT 24 11 DP;
4) Sell By Dates of OCT 23 11 DP & OCT 24 11 DP
5) Sell By Dates of OCT 23 11 DP & OCT 24 11 DP;
6) Sell By Dates OCT 23 11 DP & OCT 23 11 DP
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kroger Co., Cincinnati, OH, by e-mail on December 17, 2010 and by press release on December 18, 2010.
Manufacturer: Delight Products Co., Springfield, TN. North Carolina initiated recall is ongoing.
REASON
The Kroger Co. is recalling select packages of pet food sold in some of its retail stores because the products may contain aflatoxin, which poses a health risk to pets.
VOLUME OF PRODUCT IN COMMERCE
1,222,145 pounds of animal food
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II
___________________________________
PRODUCT
Nutrena NutreBeef Calf Grower Pellet 12/1.5 (M12) (STL) Medicated, Active Drug Ingredient Monensin 24 grams/ton, 50 lb bag, Ingredients: Grain Products, Plant Protein Products, Processed Grain By-products, Forage Products, Molasses products, Hemicellulose Extract. Recall # V-168-2011
CODE
Lot # 4F10061064
RECALLING FIRM/MANUFACTURER
Cargill Animal Nutrition, Sterling, CO, by telephone beginning April 5, 2011. Montana initiated recall is ongoing.
REASON
Medicated calf feed contains elevated levels of Monensin.
VOLUME OF PRODUCT IN COMMERCE
160 / 50 lb bags
DISTRIBUTION
MT, WY, UT
 
END OF ENFORCEMENT REPORT FOR JUNE 15, 2011
 

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