United StatesHydroxyzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 pint), Rx only (NDC 70954-912-10), Lot S25133A, distributed by ANI Pharmaceuticals, Baudette, MN, is being recalled (6564 bottles sold nationwide in the USA). The product was recalled because of the presence of a foreign substance. The recall is ongoing.
What's being recalled
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10
Recalling firm: ANI Pharmaceuticals, Inc., Baudette, MN, United States.
How to identify it
Lot S25133A
The hazard
Presence of foreign substance
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)