Recalls / Class III
Class IIID-1083-2015
Product
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
- Affected lot / code info
- Lot #: 3051728, 3053762, Exp. 4/2015
Why it was recalled
Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
Recalling firm
- Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, N/A, Rockford, Illinois 61103-1201
Distribution
- Quantity
- 1,363 UD Cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-03-26
- FDA classified
- 2015-05-15
- Posted by FDA
- 2015-05-27
- Terminated
- 2015-08-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1083-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.