Class IICompleted

Fexofenadine Hydrochloride Tablets recall

FDA recall D-0273-2024 · initiated Jan 18, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Details

Product: Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.
Recalling company: Sun Pharm Industries
Classification: Class II
Status: Completed
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Initiated: Jan 18, 2024
FDA report date: Jan 31, 2024

This recall is linked to a product we cover: Fexofenadine Hydrochloride Hives →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0273-2024 ↗

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