EPI Health, LLC: Drug Recall

Recall #D-0474-2024 · 04/23/2024

Class II: Risk

Recall Details

Recall Number
D-0474-2024
Classification
Class II
Product Type
Drug
Recalling Firm
EPI Health, LLC
Status
Terminated
Date Initiated
04/23/2024
Location
Charleston, SC, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12808 bottles

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.

Distribution Pattern

US Nationwide

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.