Drug product
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.
D-0474-2024
Product summary
- Firm
- EPI Health, LLC
- Event
- Event 94447
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12808 bottles
- Official record key
drug-enforcement:D-0474-2024
Official wording
Reason: 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.
Code information: lot # T2300765- exp. 11/30/2025 lot# T2201702A-exp. 02/28/2025 lot# T2201699- exp. 2/28/2025 lot# T2201698- exp. 2/28/2025
Distribution pattern: US Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviation