FDA Recall Terminated Historical recordClass III
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.
- Reason
- Failed Dissolution Specifications: low out of specification results for dissolution testing.
- Published
- February 12, 2020
- Distribution
- Nationwide
