United StatesbusPIRone Hydrochloride Tablets, USP, 5 mg, 500‑count bottle (NDC 29300‑244‑05), lot ZBUL25001, exp 12/31/2027, manufactured by Unichem Laboratories Ltd. for Unichem Pharmaceuticals USA Inc., are affected. The product is being recalled nationwide in the United States because the drug is subpotent; 10,875 bottles are included in the recall.
What's being recalled
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
Recalling firm: Unichem Pharmaceuticals USA Inc., East Brunswick, NJ, United States.
How to identify it
Lot: ZBUL25001, Exp 12/31/2027
The hazard
Subpotent drug
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
USA Nationwide
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)