FDA Recall
Terminated
Historical recordClass II
Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant), 4 FL OZ. bottle (118 mL), Distributed by: Pfizer, Madison, NJ 07940 USA, UPC: 50300318760128, NDC: 0031-8760-12.
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
- Published
- July 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61
by The Harvard Drug Group
- Reason
- CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
- Published
- July 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665
by Beaming White Llc
- Reason
- Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
- Published
- July 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665
by Beaming White Llc
- Reason
- Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
- Published
- July 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665
by Beaming White Llc
- Reason
- Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
- Published
- July 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Beyond Better Foods Llc
- Product
- Enlightened Dairy-Free Chocolate Peanut Butter Frozen Desser…
- Reason
- Product may contain undeclared milk. Chocolate Peanut Butter ice cream may be filled in pint sized Dairy-Free Chocolate Peanut Butter containers that have a lid labeled Chocolate Peanut Butter without the "Dairy-Free" callout.
- Published
- July 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Trident Seafoods Corporation
- Product
- Gordon Choice Imitation Crab Supreme Style, Net Wt 40 oz (2…
- Reason
- Product may contain undeclared egg white.
- Published
- July 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Mount Franklin Foods LLC
- Product
- 7-Select Yogurt Pretzels Naturally Flavored Vanilla Crunchy…
- Reason
- Potential to contain undeclared peanuts
- Published
- July 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Brill Inc
- Product
- Brill 30 lb. cases of 480 1.0 oz. chocolate chip with mini c…
- Reason
- Products may contain undeclared walnuts.
- Published
- July 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90
by Amneal Pharmaceuticals of New York, LLC
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11
by American Health Packaging
- Reason
- Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05
by Aurobindo Pharma USA Inc.
- Reason
- Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07863, Manufactured by: FDC Limited B-8, MDC Industrial Area, Waluj, Aurangabad - 431-136 Maharashtra, India, NDC 64980-513-05
by Rising Pharmaceuticals, Inc.
- Reason
- Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663, Manufactured by: FDC Limited B-8, MIDC Industrial Area, Waluj, Aurangbad - 431 136 Marahastra, India, NDC 64980-514-05
by Rising Pharmaceuticals, Inc.
- Reason
- Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01
by Marksans Pharma Limited
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK
by Amneal Pharmaceuticals of New York, LLC
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-0178-11
by Amneal Pharmaceuticals of New York, LLC
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-10
by Amneal Pharmaceuticals of New York, LLC
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05
by Amneal Pharmaceuticals of New York, LLC
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK
by Amneal Pharmaceuticals of New York, LLC
- Reason
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Published
- July 1, 2020
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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