United StatesCetirizine Hydrochloride Tablets USP 10 mg in 100-tablet bottles (NDC 16571-402-10) and 500-tablet bottles (NDC 16571-402-50), manufactured by Unique Pharmaceuticals Labs (a division of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai, and distributed by Rising Pharma Holdings, Inc., are being recalled; affected lots are PY925014A (exp. 1/31/2028) and PY925014 and PY925013 (exp. 1/31/2028). The recall was issued because tablets/capsules are imprinted with the wrong ID.
What's being recalled
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-10.
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-402-50
Recalling firm: JB Chemicals and Pharmaceuticals Ltd, Mumbai, India.
How to identify it
Lot # PY925014A; Exp. 1/31/2028 Lot # PY925014, PY925013, Exp. 1/31/2028
The hazard
Tablet/Capsules Imprinted with Wrong ID
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
U.S. 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)