Drug recall D-0827-2020
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.
Lots and codes
Lot #: 19140414, Exp 12/2020
Recall details
- Recalling firm
- Ascend Laboratories LLC, Parsippany, NJ
- Quantity
- 4728 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 22, 2020
- Terminated
- October 27, 2021
Related products
- Minocycline Hydrochloride – drug information
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