Drug 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.
D-0010-2018
Product summary
- Event
- Event 78218
- Status
- Terminated
- Classification
- Class II
- Quantity
- 96,876 bottles
- Official record key
drug-enforcement:D-0010-2018
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Code information: Lot #: GBOL16001, GBOL16002, Exp 12/31/2017; GBOL16015, Exp 03/31/2018.
Distribution pattern: Product was distributed nationwide
Derived failure modes
-
Potency or specification failure
Out of Specification