United StatesAmantadine HCl capsules, UPS 100 mg, 50 capsules (5 x 10) unit dose, NDC 50268-069-15, lot #49261, exp 04/30/27, manufactured for AvKARE (Pulaski, TN) are being recalled. The recall was initiated due to an out-of-specification dissolution finding; the product was distributed nationwide in the USA.
What's being recalled
Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.
Recalling firm: AvKARE, Pulaski, TN, United States.
How to identify it
Lot # 49261, Exp: 04/30/27
The hazard
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
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)