Recalls / Class III
Class IIID-0435-2015
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.
- Affected lot / code info
- Lot #: 3047303, Exp 04/2015
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 13,856 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-03-11
- FDA classified
- 2015-04-07
- Posted by FDA
- 2015-04-15
- Terminated
- 2015-10-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0435-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.