Recalls / Class II
Class IID-0229-2022
Product
Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 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 20140282, exp Dec 2021
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Ascend Laboratories LLC
- Manufacturer
- 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
- 4104 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-11-03
- FDA classified
- 2021-11-09
- Posted by FDA
- 2021-11-17
- Terminated
- 2022-12-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0229-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.