drugs Class III Updated 2015-04-15

Mylan Pharmaceuticals Inc. recalls Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine

Recalled Product

Fexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, USA.

Hazard / Issue

Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 3047303, Exp 04/2015
View official government recall

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