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.
Reported: October 25, 2017 Initiated: October 2, 2017 #D-0010-2018
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.
Details
- Recalling Firm
- Unichem Pharmaceuticals Usa Inc
- Units Affected
- 96,876 bottles
- Distribution
- Product was distributed nationwide
- Location
- Hasbrouck Heights, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Unichem Pharmaceuticals Usa Inc. Units affected: 96,876 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 25, 2017. Severity: Moderate. Recall number: D-0010-2018.
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