Recalls / Class II
Class IID-0179-2021
Product
Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68
- Brand name
- Cephalexin
- Generic name
- Cephalexin
- Active ingredient
- Cephalexin
- Route
- Oral
- NDCs
- 67877-544, 67877-545
- FDA application
- ANDA210221
- Affected lot / code info
- 20141680, 20141681, 20141759
Why it was recalled
Failed Impurity/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
- 9,524 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-12-17
- FDA classified
- 2020-12-30
- Posted by FDA
- 2021-01-06
- Terminated
- 2023-05-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0179-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.