Drug recall D-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
Reason for recall
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Lots and codes
Lot #: 19141869, 19141870, EXP 3/2021; 19142762, EXP 5/2021; 19143826, 19143923,19143941, 19143954 EXP 7/2021
Recall details
- Recalling firm
- Ascend Laboratories LLC, Parsippany, NJ
- Quantity
- 23,436 200 mL bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 22, 2021
- Terminated
- December 2, 2022
Related products
- Cephalexin – drug information
- NDC 67877-544 Cephalexin · Cephalexin 125 mg/5mL · Ascend Laboratories, LLC
- NDC 67877-545 Cephalexin · Cephalexin 250 mg/5mL · Ascend Laboratories, LLC