Reason: Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
D-027-2013October 31, 2012East Brunswick, NJ
Watson Laboratories Inc
Class IITerminated
Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson La...
Reason: Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochl...
D-014-2013October 31, 2012Corona, CA
Abc Compounding Company Inc
Class IIITerminated
Earth Force, Ltd., Power Towels, QS Plus Hand Sanitizing Wipes (antiseptic), 50 pre-moistened Wipes, Manufactured by: ABC Compounding Co., Inc., P.O. Box 16247, Atlanta, GA 30321.
Reason: Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover).
D-011-2013October 31, 2012Morrow, GA
Raritan Pharmaceuticals, Inc.
Class IITerminated
Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 400 capsules per bottle, Distributed by: BJWC, 25 Research Drive, Westborough, MA 01581, Made in USA, UPC...
Reason: Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
D-028-2013October 31, 2012East Brunswick, NJ
Mylan Pharmaceuticals Inc.
Class IITerminated
Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***Rx Only*** Carole Park QLD 4300, Australia*** Manufactured for...
Reason: Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
D-033-2013October 31, 2012Morgantown, WV
Raritan Pharmaceuticals, Inc.
Class IITerminated
Premier Value Fiber Plus Calcium Supplement Capsules, 120 capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL, UPC 8-40986-01987-6
Reason: Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Reason: Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
D-024-2013October 31, 2012East Brunswick, NJ
Raritan Pharmaceuticals, Inc.
Class IITerminated
DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-11925-1.
Reason: Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Reason: Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
D-023-2013October 31, 2012East Brunswick, NJ
Raritan Pharmaceuticals, Inc.
Class IITerminated
Premier Value Fiber Capsules, Fiber Capsules, 100% Natural Psyllium Fiber, Relieves Constipation, Restores Regularity, 160 Capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, ...
Reason: Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
D-030-2013October 31, 2012East Brunswick, NJ
Raritan Pharmaceuticals, Inc.
Class IITerminated
Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Supplement, Fiber Laxative for Regularity, 400 capsules per bottle, Distributed by: SAM'S West, Inc., Bentonville, AR 72716,...
Reason: Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
D-029-2013October 31, 2012East Brunswick, NJ
Raritan Pharmaceuticals, Inc.
Class IITerminated
Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fiber Laxative, 100 capsules per bottle, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, KS 06106, UPC 0-70038-6...
Reason: Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
D-021-2013October 31, 2012East Brunswick, NJ
Baxter Healthcare Corp.
Class IITerminated
10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03
Reason: Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
D-1687-2012October 3, 2012Round Lake, IL
Baxter Healthcare Corp.
Class IITerminated
0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Hea...
Reason: Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
D-1689-2012October 3, 2012Round Lake, IL
Baxter Healthcare Corp.
Class IITerminated
Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Health...
Reason: Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
D-1690-2012October 3, 2012Round Lake, IL
Baxter Healthcare Corp.
Class IITerminated
5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03
Reason: Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
D-1688-2012October 3, 2012Round Lake, IL
Baxter Healthcare Corp.
Class IITerminated
5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Co...
Reason: Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
D-1686-2012October 3, 2012Round Lake, IL
Dukal Corp.
Class IITerminated
Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged swabs per box. Item 854 contains 200 individually packaged swab...
Reason: Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
D-1676-2012September 26, 2012Ronkonkoma, NY
Dukal Corp.
Class IITerminated
ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 10...
Reason: Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
Reason: Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
D-1664-2012September 5, 2012Santa Fe Springs, CA
Bayer HealthCare Pharmaceuticals Inc.
Class IITerminated
Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin.
Reason: Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due to cross contamination with another product.
D-1433-2012August 8, 2012Wayne, NJ
Fougera Pharmaceuticals, Inc.
Class IIITerminated
Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215...
Reason: Chemical Contamination: This product is being recalled because trace amounts of a plasticizer (Di-Octyl Phthalate) may be present in the product.
D-1426-2012August 1, 2012Hicksville, NY
Kimberly-Clark Corporation
Class IITerminated
Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Distributed by Kimberly Clark, LLC, Roswell, GA 30076
Reason: Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.