Class II
Terminated
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.
This recall has been terminated (originally issued October 25, 2017).
- Company
- Unichem Pharmaceuticals Usa Inc
- Recall Initiated
- October 2, 2017
- Posted
- October 25, 2017
- Recall Number
- D-0010-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 96,876 bottles
- Firm Location
- Hasbrouck Heights, NJ, United States
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot #: GBOL16001, GBOL16002, Exp 12/31/2017; GBOL16015, Exp 03/31/2018.
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