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.

Recall Number: D-0827-2020

Firm: Ascend Laboratories LLC

Classification: Class III

Status: Terminated

Report Date: 20200212

Initiation Date: 20200122

Termination Date: 20211027

Failed Dissolution Specifications: low out of specification results for dissolution testing.

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.