Recall: D-0827-2020

Class III - Minor Violations

Class IIIClassification

2020-01-22Initiated

TerminatedStatus

Ascend Laboratories LLCFirm

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

Failed Dissolution Specifications: low out of specification results for dissolution testing.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.