Unichem Pharmaceuticals Usa Inc recalls Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind.…

Recall date

October 2, 2017

Source

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

Recall number

D-0010-2018

FDA classification

Class II

Brand / firm

Unichem Pharmaceuticals Usa Inc

Sold / distributed

Product was distributed nationwide

Why it was recalled

Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa, 403 511, India, Marketed by: UNICHEM PHARMACEUTICALS, (USA), INC. Hasbrouck Heights, NJ 07604, NDC 29300-126-13.