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…

Recall date

March 26, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1083-2015

FDA classification

Class III

Brand / firm

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

Sold / distributed

Nationwide

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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