Unichem Pharmaceuticals Usa Inc recalls Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind.
Recalled October 25, 2017 · FDA recall D-0010-2018 · Unichem Pharmaceuticals Usa
Hazard
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing. · FDA Class II
Units
96,876 bottles
Sold at
Product was distributed nationwide
Description
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Product
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.
Manufacturer(s)
Unichem Pharmaceuticals Usa Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →