Recalls / Class II
Class IID-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.
- Brand name
- Bisoprolol Fumarate
- Generic name
- Bisoprolol Fumarate
- Active ingredient
- Bisoprolol Fumarate
- Route
- Oral
- NDCs
- 29300-126, 29300-127
- FDA application
- ANDA078635
- Affected lot / code info
- Lot #: GBOL16001, GBOL16002, Exp 12/31/2017; GBOL16015, Exp 03/31/2018.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Recalling firm
- Firm
- Unichem Pharmaceuticals Usa Inc
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 777 Terrace Ave, Suite 102, Hasbrouck Heights, New Jersey 07604-3102
Distribution
- Quantity
- 96,876 bottles
- Distribution pattern
- Product was distributed nationwide
Timeline
- Recall initiated
- 2017-10-02
- FDA classified
- 2017-10-18
- Posted by FDA
- 2017-10-25
- Terminated
- 2018-09-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0010-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.