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.
FDA recall notice · announced February 12, 2020 · Ascend Laboratories
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The 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.
Reason for recall
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Notes
Distribution: Nationwide in the USA
Lot/code information: Lot #: 19140414, Exp 12/2020
Quantity: 4728 bottles
Status: Terminated
Products in this recall event:
- 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, (D-0827-2020)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.