Drug 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

D-1083-2015

March 26, 2015

Class III

Product summary

Firm: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Event: Event 70857
Status: Terminated
Classification: Class III
Quantity: 1,363 UD Cartons
Official record key: drug-enforcement:D-1083-2015

Official wording

Reason: Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing

Code information: Lot #: 3051728, 3053762, Exp. 4/2015

Distribution pattern: Nationwide

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Failed Impurities/Degradation Specifications