Drug product
Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.
D-0827-2020
Product summary
- Event
- Event 84750
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4728 bottles
- Official record key
drug-enforcement:D-0827-2020
Official wording
Reason: Failed Dissolution Specifications: low out of specification results for dissolution testing.
Code information: Lot #: 19140414, Exp 12/2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification