FDA recall D-0010-2018

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.

Distribution

Product was distributed nationwide

Key facts

Status

Terminated

Initiation date

2017-10-02

Report date

2017-10-25

Termination date

2018-09-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hasbrouck Heights, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0010-2018