Ascend Laboratories LLC recalls Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Labor
Recalled February 12, 2020 · FDA recall D-0827-2020 · Ascend Laboratories
Hazard
Failed Dissolution Specifications: low out of specification results for dissolution testing. · FDA Class III
Units
4728 bottles
Sold at
Nationwide in the USA
Description
Failed Dissolution Specifications: low out of specification results for dissolution testing.
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.
Manufacturer(s)
Ascend Laboratories LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →