← FDA ENFORCEMENT
D-0474-2024Class II

EPI Health, LLC

Recalling firm
EPI Health, LLC
Product type
Drug
Status
Terminated
Report date
2024-05-01
Distribution
US Nationwide
Firm state
SC
Product quantity
12808 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
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, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-101-30.

Code / lot info

lot # T2300765- exp. 11/30/2025 lot# T2201702A-exp. 02/28/2025 lot# T2201699- exp. 2/28/2025 lot# T2201698- exp. 2/28/2025

Other recalls SPEQ maps to Risk Management & CAPA
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See all Risk Management & CAPA recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.