Is Carbidopa and Levodopa Extended-Release Tablets, 25/100 mg, a) 100-count bottle (NDC 60505-0131-1), b) 1000-count bottle (NDC 60505-0131-0), Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL 33326. recalled?

Medium RiskFDA Drug

Apotex Corp.: CGMP Deviations: Apotex, Inc. Canada, is recalling multiple pharmaceutical products for cGMP violations that may have resulted in product cross contamination.

Agency Publication Date: September 8, 2010

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 56030

Status: Resolved

Manufacturer: Apotex Corp.

Manufactured In: United States

Units Affected: 27 products (99,035 bottles; 179,502 bottles; 51,298 bottles; 3,764 bottles; 138,981 bottles; 211,296 bottles; 45,190 bottles; 134,864 bottles; 283,918 bottles; 292,667 bottles; 71,390 bottles; 38,398 bottles; 61,986 bottles; 89,941 bottles; 42,727 bottles; 126,635 bottles; 18,738 bottles; 258,173 bottles; 106,089 bottles; 38,993 bottles; 2,907 bottles; 1,056 bottles; 6,581,432 bottles and cartons; 179,405 bottles; 539,475 bottles; 12,601 bottles; 15,924 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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