January 08, 2021
Ascend Laboratories is recalling multiple lots of cephalexin for oral suspension. The January 6, 2021, US Food and Drug Administration (FDA) Enforcement Report stated that the drug failed to meet impurity/degradation specifications.
The recall affects the following products, which were manufactured by Alkem Laboratories and distributed throughout the United States by Ascend Laboratories:
- cephalexin for oral suspension (NDC 67877-545-88), 250 mg/5 mL, 100 mL (when mixed), from lots 20141674, 20141675, 20141676, 20141677, and 20141678; and
- cephalexin for oral suspension (NDC 67877-545-68), 250 mg/5 mL, 200 mL (when mixed), from lots 20141680, 20141681, and 20141759.
Ascend Laboratories voluntarily initiated the recall December 17, 2020. The FDA designated the recall Class II on December 30, 2020. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. Although remote, a possibility of serious harm also exists.
Cephalexin is a prescription cephalosporin antibiotic used to treat a wide variety of bacterial infections.