August 7, 2019DrugsFDA
NingBo Huize Commodity Co.,Ltd. recalls CHARMS BLOW POP CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL
Hazard: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
August 7, 2019DrugsFDA
NingBo Huize Commodity Co.,Ltd. recalls DOTS SCENTED ANTIBACTERIAL HAND GEL LEMON (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises,
Hazard: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
August 7, 2019DrugsFDA
NingBo Huize Commodity Co.,Ltd. recalls DOTS SCENTED ANTIBACTERIAL HAND GEL STRAWBRRY (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterpri
Hazard: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
August 7, 2019DrugsFDA
NingBo Huize Commodity Co.,Ltd. recalls DOTS SCENTED ANTIBACTERIAL HAND GEL LIME (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises,
Hazard: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
August 7, 2019DrugsFDA
NingBo Huize Commodity Co.,Ltd. recalls DOTS SCENTED ANTIBACTERIAL HAND GEL ORANGE (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises
Hazard: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
August 7, 2019DrugsFDA
NingBo Huize Commodity Co.,Ltd. recalls Tootsie Roll POP RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by:
Hazard: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
August 7, 2019DrugsFDA
NingBo Huize Commodity Co.,Ltd. recalls Tootsie Roll POP CHOCOLATE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by:
Hazard: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
August 7, 2019DrugsFDA
NingBo Huize Commodity Co.,Ltd. recalls Tootsie Roll POP ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL
Hazard: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
August 7, 2019DrugsFDA
NingBo Huize Commodity Co.,Ltd. recalls Texas Home Health Home Care Hospice Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in China
Hazard: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
August 7, 2019DrugsFDA
NingBo Huize Commodity Co.,Ltd. recalls festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%,
Hazard: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
August 7, 2019DrugsFDA
NingBo Huize Commodity Co.,Ltd. recalls SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunsc
Hazard: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
August 7, 2019DrugsFDA
NingBo Huize Commodity Co.,Ltd. recalls Tootsie Roll POP GRAPE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed By: JFL
Hazard: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
August 7, 2019DrugsFDA
NingBo Huize Commodity Co.,Ltd. recalls Good to Go Hand Sanitizer (Ethyl Alcohol 62%), 1 FL OZ (30 mL), OTC, Made in China for Cashco Distributors Inc. 6430 N.
Hazard: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
August 7, 2019DrugsFDA
NingBo Huize Commodity Co.,Ltd. recalls Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl Alcohol 62%), 0.33 oz/10 mL, OTC, Made in
Hazard: CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
July 31, 2019DrugsFDA
Ucb, Inc recalls Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manufactured for UCB, Inc. Smyrna, GA 30080, ND
Hazard: Failed Dissolution Specifications.
July 31, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharma
Hazard: Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
July 31, 2019DrugsFDA
La Fresh Group, Inc. recalls LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, soft & moisturizing featuring titanium diox
Hazard: 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.
July 31, 2019DrugsFDA
Dercher Enterprises, Inc., DBA Gordon Laboratories recalls MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box,
Hazard: 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.
July 31, 2019DrugsFDA
Geritrex, LLC recalls Preferred Plus Dioctyl Liquid Stool Softener (Docusate Sodium), 50mg/5mL, 16 FL. Oz. (1 PT.) 473 mL, Manufactured by RIJ
Hazard: cGMP Deviations: Products may have microbial contamination.
July 31, 2019DrugsFDA
Geritrex, LLC recalls Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd Street Brooklyn, NY, NDC 57896-660
Hazard: cGMP Deviations: Products may have microbial contamination.
July 31, 2019DrugsFDA
Geritrex, LLC recalls Ritussin DM Double Strength, 4 FL. OZ. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 1094
Hazard: cGMP Deviations: Products may have microbial contamination.
July 31, 2019DrugsFDA
Geritrex, LLC recalls Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceutica
Hazard: cGMP Deviations: Products may have microbial contamination.
July 31, 2019DrugsFDA
Geritrex, LLC recalls Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals C
Hazard: cGMP Deviations: Products may have microbial contamination.
July 31, 2019DrugsFDA
Geritrex, LLC recalls Gericare Diocto Liquid Docusate Sodium Stool Softener, 50 mg/5mL, 16 FL OZ (473 ml), Dist. BY: Gericare Pharmaceuticals
Hazard: cGMP Deviations: Products may have microbial contamination.
July 31, 2019DrugsFDA
Geritrex, LLC recalls Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10
Hazard: cGMP Deviations: Products may have microbial contamination.
July 31, 2019DrugsFDA
Geritrex, LLC recalls Diphenhydramine Oral Liquid Alcohol Free, 12.5 mg/5 mL, 4 fl oz (118 mL), RIJ Pharmaceutical Corporation 40 Commercial A
Hazard: cGMP Deviations: Products may have microbial contamination.
July 31, 2019DrugsFDA
Bionpharma Inc. recalls Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Prince
Hazard: Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
July 31, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmac
Hazard: Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
July 31, 2019DrugsFDA
Tris Pharma Inc. recalls Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bit
Hazard: 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.
July 31, 2019DrugsFDA
Amneal Pharmaceuticals, Inc. recalls Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) and b) 28 count bottles (NDC 69238-1605-08)
Hazard: Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets