Recalls / Class II
Class IID-0185-2021
Product
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA. Distributed by: Ascend Lab,oratories, LLC Parsippany, NJ 07054
- Brand name
- Cephalexin
- Generic name
- Cephalexin
- Active ingredient
- Cephalexin
- Route
- Oral
- NDCs
- 67877-544, 67877-545
- FDA application
- ANDA210221
- Affected lot / code info
- Lot#: a) 19144340, 19144341, Exp AUG 2021; b) 20142226, 20142227, Exp MAY 2022
Why it was recalled
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
Recalling firm
- Firm
- Ascend Laboratories LLC
- Manufacturer
- Ascend Laboratories, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 20,232 bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-11-23
- FDA classified
- 2021-01-04
- Posted by FDA
- 2021-01-13
- Terminated
- 2023-06-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0185-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.