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.
Reason for recall: Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Recall initiated: 20150311
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated