Recalls / Class II
Class IID-0359-2022
Product
Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50
- Brand name
- Cefixime
- Generic name
- Cefixime
- Active ingredient
- Cefixime
- Route
- Oral
- NDC
- 67877-584
- FDA application
- ANDA210574
- Affected lot / code info
- Lot #: 20140293, Exp Dec 2021; 20141525, 20141526, 20141527, Exp Mar 2022; 20143019, 20143020, 20143021, 20143022, Exp July 2022; 20144759, 20144760, 20144761, Exp Nov 22
Why it was recalled
Failed impurities/degradation specifications
Recalling firm
- Firm
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, N/A, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 42,698 bottles
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2021-12-21
- FDA classified
- 2022-01-05
- Posted by FDA
- 2022-01-12
- Terminated
- 2023-04-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0359-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.