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FDARecalled Jan 31, 2024 · #D-0273-2024

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 I...

Hazard

Class II — temporary health risk

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Description

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Classification: Class II Distribution: Nationwide in the USA

Product 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.
Type
Drugs
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Model numbers
UPCs