Class II

Drug Recall: minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403,

EPI Health, LLC · April 23, 2024

Reason for Recall

CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Product Description

minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-102-30.

Distribution

US Nationwide

States Affected

NATIONWIDE

Quantity Affected

5664 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0475-2024

Status: terminated

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