🍔 Food 💊 Drugs 🏥 Medical Devices
(No Brand) First Aid Kit, 326 Piece Kit. Product labeling reads in part: BE SMART GET PREPARED,326 Pieces of Name Brand & Quality First Aid Supplies, FIRST AID, Total Resources International, Walnut, CA 91789 Class II

Reason: CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.

Total Resources Intl 20130409 Terminated
Distributed: Nationwide
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Medi-First Brand First Aid Kit, MEDI-FIRST 61 Piece Kit, Home, Workplace Travel, Sport, Total Resources International, Walnut, CA 91789 Class II

Reason: CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.

Total Resources Intl 20130409 Terminated
Distributed: Nationwide
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3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Walnut, CA 91789 Class II

Reason: CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.

Total Resources Intl 20130409 Terminated
Distributed: Nationwide
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Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons. Class III

Reason: Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP

Hi-Tech Pharmacal Co., Inc. 20130725 Terminated
Distributed: Nationwide and Puerto Rico
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Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33 Class II

Reason: Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel

Hospira Inc. 20130525 Terminated
Distributed: Nationwide
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Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887 Class II

Reason: Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.

Sanofi-Synthelabo 20130226 Terminated
Distributed: Canada
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Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-EM Canada Inc. Anjou Quebec H1J2Z4, Canada, NDC 0270-0445-40 Class II

Reason: Presence of foreign substance: One lot of the product may contain black foreign particles

Bracco Diagnostics Inc 20130621 Terminated
Distributed: Nationwide
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Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist. By: Wal-Mart Stores, Inc., Bentonville, AR 72710, NDC 49035-404-61 b)Equaline brand maximum strength heartburn relief, , DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344, NDC 41163-404-61, c)Wal-Zan brand 150, MAXIMUM STRENGTH, 24 count bottlle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 63015, NDC 0363-0404-34 Class II

Reason: Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.

Dr. Reddy's Laboratories, Inc. 20130802 Terminated
Distributed: Nationwide
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Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724. Class II

Reason: Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets

West-Ward Pharmaceutical Corp. 20130730 Terminated
Distributed: Nationwide
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Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20 Class III

Reason: Labeling: Missing Label; missing label on blister card

Boehringer Ingelheim Roxane Inc 20130614 Terminated
Distributed: Nationwide
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