Class III
Terminated
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.
- Company
- Ascend Laboratories, Llc
- Recall Initiated
- January 22, 2020
- Posted
- February 12, 2020
- Recall Number
- D-0827-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4728 bottles
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: 19140414, Exp 12/2020
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