United StatesMinocycline Hydrochloride Extended‑Release Tablets, USP, 115 mg, 30‑count bottles (NDC 67877‑644‑30), Lot 25141635, exp 4/30/2028, manufactured by Alkem Laboratories Ltd. and distributed by Ascend Laboratories, LLC, are affected. They were recalled because an out‑of‑specification dissolution result was observed during the ninth‑month dissolution test; 360 30‑count bottles distributed nationwide in the USA are included in the ongoing recall.
What's being recalled
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30
Recalling firm: Ascend Laboratories, LLC, Bedminster, NJ, United States.
How to identify it
Lot# 25141635, Exp 4/30/2028
The hazard
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)