🍔 Food 💊 Drugs 🏥 Medical Devices
Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-8858-1. Class III

Reason: Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'

Bryant Ranch Prepack, Inc. 20240510 Ongoing
Distributed: Nationwide in the USA
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Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9205-1. Class III

Reason: Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g

Bryant Ranch Prepack, Inc. 20240510 Ongoing
Distributed: Nationwide in the USA
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Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1. Class III

Reason: Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'

Bryant Ranch Prepack, Inc. 20240510 Ongoing
Distributed: Nationwide in the USA
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Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06 Class II

Reason: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Glenmark Pharmaceuticals Inc., USA 20240513 Ongoing
Distributed: US Nationwide.
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Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06 Class II

Reason: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Glenmark Pharmaceuticals Inc., USA 20240513 Ongoing
Distributed: US Nationwide.
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Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99 Class II

Reason: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Glenmark Pharmaceuticals Inc., USA 20240510 Ongoing
Distributed: US Nationwide.
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Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99 Class II

Reason: CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Glenmark Pharmaceuticals Inc., USA 20240510 Ongoing
Distributed: US Nationwide.
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EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01, NDC (sample lot) 61755-005-54 Class II

Reason: Lack of Assurance of Sterility: Complaints of syringe breakage

Regeneron Pharmaceuticals Inc 20240515 Terminated
Distributed: USA nationwide.
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ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 4 OZ (113g), Manufactured for AGS Brands. UPC 0 17971 10421 7 Class II

Reason: Out of Specification for active ingredient

ARG Laboratories, Inc. 20240417 Ongoing
Distributed: Distributed Nationwide in the USA
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NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%)Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM, Roll-On NET WT 3 fl. oz. (88.7ml), Manufactured for Golden Tiger USA Albuquerque, NM, UPC 1 82294 00006 2 Class II

Reason: Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.

ARG Laboratories, Inc. 20240417 Ongoing
Distributed: Distributed Nationwide in the USA
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