D-0827-2020 Class III Terminated
FDA drug recall D-0827-2020 was initiated by Ascend Laboratories LLC on January 22, 2020 and is designated Class III. Reason for recall: Failed Dissolution Specifications: low out of specification results for dissolution testing. The recall status is terminated (terminated October 27, 2021). Affected quantity: 4728 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 12, 2020
- Initiation Date
- January 22, 2020
- Termination Date
- October 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4728 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 19140414, Exp 12/2020