Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons,

Recalled May 27, 2015 · FDA recall D-1083-2015 · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Hazard

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

Units

1,363 UD Cartons

Sold at

Nationwide

Description

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

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

Manufacturer(s)

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

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →