Drug product
minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only, Mfg by: Dr. Reddy's Laboratories Limited, FTO-SEZ, Process Unit-01 Devunipalavalasa Village Srikakulam (District) Andhra Pradesh, INDIA. Manufactured for: EPI Health, LLC 134 Columbus St. Charleston, SC 29403 USA. NDC 71403-102-05.
D-0120-2020
Product summary
- Firm
- EPI Health, LLC
- Event
- Event 83809
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,626 5-count bottles
- Official record key
drug-enforcement:D-0120-2020
Official wording
Reason: Failed Dissolution Specifications:
Code information: Lot# T900093, Exp 11/2020
Distribution pattern: Firm recalling only from EPI Field Representatives.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications