Is Chlordiazepoxide and Clidinium Bromide Capsules, 5mg/2.5mg, 100, 500 and 1000 capsule bottles, Rx only, Manufactured by Actavis Totowa LLC, Totowa, NJ ---- NDC 52152-018-02, 52152-018-04, 52152-18-05; Also labeled under Amide Pharmaceutical Inc. recalled?

Medium RiskFDA Drug

Actavis Totowa LLC: Subpotent; 18 month stability; Subpotent; 18month stability; Subpotent; carisoprodol; Subpotent; acetaminophen and dichloralphenazone; Exceeded Impurity Specification; Superpotent, thiamine; Superpotent; thiamine; Superpotent; phentermine HCl; Subpotent; homatropine methylbromide; cGMP Deviations; lack of stability data to support expiry

Agency Publication Date: July 25, 2008

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 48071

Status: Resolved

Manufacturer: Actavis Totowa LLC

Manufactured In: United States

Units Affected: 19 products (65 lots: 565,797 bottles; 18 lots; 117469 bottles; 5 lots: 2849 Actavis; 2799 Amide, 1417 Medpoint; 18 lots; 64950 bottles; 8 lots; 34742 5 x 6 blister packs; 8 lots; 42187 5 x 6 blister packs; 6 lots; ; 12272 5 x 6 blister packs; 1 lot; 924 bottles; 11 lots; 18648 bottles; 12 lots: 22452 bottles; 19 lots; Actavis: 336857, Amide: 97817; Major: 2160; 38 lots: Actavis: 593013 bottles; Amide: 302611 bottles; Major: 3312 bottles; Qualitest: 28032 bottles.; 36 lots: Actavis: 479586 bottles, Amide: 207449 bottles; Qualitest: 38356 bottles;; 23 lots; 139854 bottles; 17 lots; 157237 bottles; 19 lots; 14,913 bottles 100 count, 9578 bottles 1000 count.; 18 lots,; 51852 bottles 100 count, 7253 bottles 1000 count; 65 lots, 1,386,613 bottles; 15 lots, 42,732 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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