Home / Recalls / Unichem Pharmaceuticals Usa Inc / D-0010-2018

D-0010-2018 Class II Terminated

Recalled by Unichem Pharmaceuticals Usa Inc — Hasbrouck Heights, NJ

Recall Details

Product Type
Drugs
Report Date
October 25, 2017
Initiation Date
October 2, 2017
Termination Date
September 13, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
96,876 bottles

Product Description

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 Pattern

Product was distributed nationwide

Code Information

Lot #: GBOL16001, GBOL16002, Exp 12/31/2017; GBOL16015, Exp 03/31/2018.

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