Drug 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.
D-0435-2015
Product summary
- Event
- Event 70831
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13,856 Bottles
- Official record key
drug-enforcement:D-0435-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Code information: Lot #: 3047303, Exp 04/2015
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification