Ascend Laboratories LLC recalls Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Labo…
- Recall date
- January 22, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0827-2020
- FDA classification
- Class III
- Brand / firm
- Ascend Laboratories LLC
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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