Drug & medication recalls

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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