Recalls / Class II
Class IID-0264-2021
Product
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
- Lot #: 19141869, 19141870, EXP 3/2021; 19142762, EXP 5/2021; 19143826, 19143923,19143941, 19143954 EXP 7/2021
Why it was recalled
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Recalling firm
- Firm
- Ascend Laboratories LLC
- Manufacturer
- Ascend Laboratories, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, N/A, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 23,436 200 mL bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-01-22
- FDA classified
- 2021-02-18
- Posted by FDA
- 2021-02-24
- Terminated
- 2022-12-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0264-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.