FDA-Drug2020-02-12Class III
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.
Ascend Laboratories LLC
Hazard
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Sold states
Nationwide in the USA
Affected count
4728 bottles
Manufactured in
339 Jefferson Rd Ste 101, N/A, Parsippany, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0827-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief