FDA-Drug2017-10-25Class II
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.
Unichem Pharmaceuticals Usa Inc
Hazard
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Sold states
Product was distributed nationwide
Affected count
96,876 bottles
Manufactured in
777 Terrace Ave, Suite 102, Hasbrouck Heights, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0010-2018Don't want to check this manually?
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