Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIIDOTS SCENTED ANTIBACTERIAL HAND GEL LIME (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIIDOTS SCENTED ANTIBACTERIAL HAND GEL ORANGE (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIITootsie Roll POP RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIITootsie Roll POP CHOCOLATE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIITootsie Roll POP ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIITexas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIIfestpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen Distributed by: festpak - Austin, TX 78732 Made in China
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIISPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen, 53mL/1.8fl.oz., OTC, Distributed by: EVANS, Made in China
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIITootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed By: JFL Enterprises, Inc. Cleveland, Ohio 44102, Made in China
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIIGood to Go Hand Sanitizer (Ethyl Alcohol 62%), 1 FL OZ (30 mL), OTC, Made in China for Cashco Distributors Inc. 6430 N. E. Columbia Blvd Portland OR 97218
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-08-07FDA-DrugNingBo Huize Commodity Co.,Ltd.Class IIIAccent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
- 2019-07-31FDA-DrugUcb, IncClass IIKeppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-597-66.
Failed Dissolution Specifications.
- 2019-07-31FDA-DrugLupin Pharmaceuticals Inc.Class IILisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-519-02
Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
- 2019-07-31FDA-DrugLa Fresh Group, Inc.Class IILA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, soft & moisturizing featuring titanium dioxide, 1 wipe individually wrapped packet, 4.75" x 5.75" (12.0 cm x 14.6 cm) Ingredients: Water, Dimethicone, Dimethiconol, Titanium Dioxide, Benzophenone-3, Octinoxate, Ethylhexylglycerine, Phenoxyethanol, Distributed by La Fresh Group, Inc. Chino, CA 91710 www.LaFreshGroup.com
Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling of the product and comments about the product found on e-commerce websites.
- 2019-07-31FDA-DrugDercher Enterprises, Inc., DBA Gordon LaboratoriesClass IIMONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.
- 2019-07-31FDA-DrugGeritrex, LLCClass IIPreferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ Pharmaceutical Corp. 40 Commercial Avenue Middletown, NY 10941, Distributed by Kinray Inc. Whitestone, NY 11357, NDC 53807-216-16
cGMP Deviations: Products may have microbial contamination.
- 2019-07-31FDA-DrugGeritrex, LLCClass IIGericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd Street Brooklyn, NY, NDC 57896-660-16
cGMP Deviations: Products may have microbial contamination.
- 2019-07-31FDA-DrugGeritrex, LLCClass IIRitussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941
cGMP Deviations: Products may have microbial contamination.
- 2019-07-31FDA-DrugGeritrex, LLCClass IIPreferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 52807-177-16
cGMP Deviations: Products may have microbial contamination.
- 2019-07-31FDA-DrugGeritrex, LLCClass IIGericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16
cGMP Deviations: Products may have microbial contamination.
- 2019-07-31FDA-DrugGeritrex, LLCClass IIGericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist. BY: Gericare Pharmaceuticals corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-403-16
cGMP Deviations: Products may have microbial contamination.
- 2019-07-31FDA-DrugGeritrex, LLCClass IIRitussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-409-04
cGMP Deviations: Products may have microbial contamination.
- 2019-07-31FDA-DrugGeritrex, LLCClass IIDiphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-204-04
cGMP Deviations: Products may have microbial contamination.
- 2019-07-31FDA-DrugBionpharma Inc.Class IIClobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC 69452-116-45.
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
- 2019-07-31FDA-DrugLupin Pharmaceuticals Inc.Class IIINystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
- 2019-07-31FDA-DrugTris Pharma Inc.Class IIHydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02.
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
- 2019-07-31FDA-DrugAmneal Pharmaceuticals, Inc.Class IIIMethylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
- 2019-07-31FDA-DrugAscend Laboratories LLCClass IIAtorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b) 500 count (NDC 67877-0514-05) bottles, Rx only, Manufactured by: Alkem Laboratories, Ltd, Mumbai INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ
Failed Dissolution Specifications
- 2019-07-31FDA-DrugBaxter Healthcare CorporationClass II0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.
Lack of Assurance of Sterility: Bags have potential to leak.
- 2019-07-31FDA-DrugDeva Holding AS - Cerkezkoy SubesiClass IITemozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey 34303, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-542-07.
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
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