FDA recall D-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.

Reason for recall

Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-03-11

Report date

2015-04-15

Termination date

2015-10-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0435-2015