Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20
Recall Number: D-1083-2015
Firm: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Classification: Class III
Status: Terminated
Report Date: 20150527
Initiation Date: 20150326
Termination Date: 20150831
Reason for Recall
Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
Product Description
Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20