Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2012-10-31FDA-DrugBristol-myers Squibb CompanyClass IBiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146 Diluent manufactured by: Luitpold Pharmaceuticals, Inc. Shirley, NY 11967 Distributed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA Made in USA NDC 0015-3012-18 NDC 0015-3012-60
Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of an overfilled vial discovered during stability testing for a single carmustine lot.
- 2012-10-31FDA-DrugAbc Compounding Company IncClass IIIEarth 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.
Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover).
- 2012-10-31FDA-DrugVintage Pharmaceuticals LLC DBA Qualitest PharmaceuticalsClass IIPerphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-5092-21.
Tablet Separation: Possibility of cracked or split coating on the tablets.
- 2012-10-24FDA-DrugEarthborn Products, Inc.Class IIColloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz (59.15 mL), b) 8 fl.oz (236.6 mL), c) 16 fl.oz (473.2 mL), d) 32 fl.oz (946.4 mL), e) 64 fl.oz (1.89 L), and f) 1 Gal. (3.78 L), Distributed by: Earthborn Products, San Diego, CA 92103.
Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.
- 2012-10-24FDA-DrugSandoz IncorporatedClass IIIChildren's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
- 2012-10-17FDA-DrugPaddock Laboratories, LLCClass IIMoexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 ,
Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (expiration 1/2014) because of a non-conformity dissolution failure result found during routine stability testing at the 6 month test interval.
- 2012-10-17FDA-DrugActavis Mid Atlantic LLCClass IIIPrometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic LLC., 1877 Kawaii Road, Lincolnton, NC 28092 USA, NDC 0472-1629-16
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
- 2012-10-17FDA-DrugActavis Mid Atlantic LLCClass IIIPrometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16.
Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.
- 2012-10-10FDA-DrugMylan Pharmaceuticals Inc.Class IIIFamotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
- 2012-10-10FDA-DrugCarefusion 213, LlcClass IIChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
- 2012-10-10FDA-DrugCaraco Pharmaceutical Laboratories Ltd.Class IINimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc.
Crystallization: Presence of crystals of Nimodipine within the capsule solution.
- 2012-10-10FDA-DrugMcKesson Packaging ServicesClass IIIbuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 450 10 3, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-450-10, carton barcode 6373945010.
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
- 2012-10-10FDA-DrugMcKesson Packaging ServicesClass IIIbuPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10, carton barcode 6373944910.
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
- 2012-10-03FDA-DrugMylan Pharmaceuticals Inc.Class IILevetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05
Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.
- 2012-10-03FDA-DrugGlenmark Generics Inc., USAClass IINAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01.
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
- 2012-10-03FDA-Drugwww.vitaminbestbuy.comClass IJapan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbestbuy.com, Brewerton, NY
Marketed Without an Approved ANDA/NDA: presence of sibutramine
- 2012-10-03FDA-Drugwww.vitaminbestbuy.comClass IMan King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American Wanbao Pharmaceutical International Group and Hainan Wanbao Biological Engineering Co., Ltd., 27 Heping Road, Haikou, Henan Province, UPC 9 009900 0032328
Marketed Without an Approved ANDA/NDA: presence of sildenafil.
- 2012-10-03FDA-Drugwww.vitaminbestbuy.comClass IHard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet
Marketed Without an Approved ANDA/NDA: presence of sildenafil
- 2012-10-03FDA-DrugBen Venue Laboratories IncClass IVecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs, Bedford, OH 44146, NDC 55390-039-10.
Presence of Particulate Matter
- 2012-10-03FDA-DrugAbbott LaboratoriesClass IISynthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-9296-90
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
- 2012-10-03FDA-DrugAbbott LaboratoriesClass IISynthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-5182-90.
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
- 2012-10-03FDA-DrugAbbott LaboratoriesClass IISynthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90.
Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the tablets.
- 2012-10-03FDA-DrugActavisClass IIFentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA, Distributed by: Watson, Pharma Inc.
Subpotent; some patches may not contain fentanyl gel
- 2012-10-03FDA-DrugMallinckrodt IncClass IIIThallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration, 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol as a preservative, RX, Mallinckrodt Inc., St. Louis, MO 63134
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
- 2012-10-03FDA-DrugDispensing Solutions, IncClass IIAtrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947
Label Mix up; side panel of sticker label applied by Dispensing Solutions Inc. incorrectly indicates product name as Ventolin HFA 90 mcg instead of correctly as Atrovent HFA 12.9 grams Inhalation Aerosol
- 2012-10-03FDA-DrugBaxter Healthcare Corp.Class IILactated 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 Healthcare Corporation, Deerfield, IL 60015 USA
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
- 2012-10-03FDA-DrugBaxter Healthcare Corp.Class II0.9% 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 Healthcare Corporation, Deerfield, IL 60015 USA
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
- 2012-10-03FDA-DrugBaxter Healthcare Corp.Class II5% 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
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
- 2012-10-03FDA-DrugBaxter Healthcare Corp.Class II10% 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
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
- 2012-10-03FDA-DrugBaxter Healthcare Corp.Class II5% 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 Corporation, Deerfield, IL 60015 USA
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
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