FDA recall D-1083-2015

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · Class III · 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

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-03-26
Report date: 2015-05-27
Termination date: 2015-08-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1083-2015