Class III
Terminated
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.
This recall has been terminated (originally issued April 15, 2015).
- Company
- Mylan Pharmaceuticals Inc.
- Recall Initiated
- March 11, 2015
- Posted
- April 15, 2015
- Recall Number
- D-0435-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 13,856 Bottles
- Firm Location
- Morgantown, WV, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Distribution
Nationwide
Lot / Code Info
Lot #: 3047303, Exp 04/2015
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