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.
Reason for recall: Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity  was observed during the 18 month stability testing.
Recall initiated: 20171002
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated