Is Amlodipine Besylate Tablets, 2.5 mg, 90 ct bottle (NDC 60505-0193-03) & 1000 ct bottle (NDC 60505-0193-02) Rx Only Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L recalled?

Medium RiskFDA Drug

Apotex Inc.: On 03/02/2011 Apotex Inc., ON Canada imitated a recall of Amlodipine Besylate Tablets, 2.5mg, 5mg, and 10mg Tablets in 90 and 1000 ct, bottles distributed between 04/17/2009 and 09/18/2009 in the US and 06/10/2009 to 04/11/2011 to Haiti. Amlodipine Besylate tablets failed routine RT stability studies. All affected accounts were notified on 03/02/2011.; Impurities/Degradation Products: Apotex Inc., Canada initiated a recall of Amlodipine Besylate Tablets, 2.5mg, 5mg, and 10mg Tablet

Agency Publication Date: January 11, 2012

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 60191

Status: Resolved

Manufacturer: Apotex Inc.

Manufactured In: Canada

Units Affected: 3 products (69,538 bottles; 264,498 bottles; 298,386 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

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