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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

Amedra Pharmaceuticals LLC: Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.

Agency Publication Date: February 27, 2013
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Affected Products

Product: Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09

Lot 238316, exp 01/31/2014

Lot Numbers:
238316
Product: Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09

Lot 220839, exp 11/30/2013

Lot Numbers:
220839
Product: Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09

Lot 220843, exp 11/30/2013

Lot Numbers:
220843

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 63926
Status: Resolved
Manufacturer: Amedra Pharmaceuticals LLC
Manufactured In: United States
Units Affected: 3 products (1,176 bottles; 12,948 bottles; 10,968 bottles)

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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.