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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

Blu Pharmaceuticals Inc: Defective container: Product distributed without inner seal on bottles.

Agency Publication Date: May 5, 2014
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Affected Products

Product: Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05

Lot # 13E0008F3P8V; Exp. 03/15

Lot Numbers:
13E0008F3P8V
Product: Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134, NDC 24658-0292-05

Lot # 13E0014F1P8V; Exp. 04/15

Lot Numbers:
13E0014F1P8V

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 67739
Status: Resolved
Manufacturer: Blu Pharmaceuticals Inc
Manufactured In: United States
Units Affected: 2 products (14,000 tablets; 101,500 tablets)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.