FDA recall D-0827-2020

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 for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2020-01-22

Report date

2020-02-12

Termination date

2021-10-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0827-2020