Antibiotic Recalled Over Impurity Findings

Ascend Laboratories is recalling nine lots of cephalexin for oral suspension because impurity results during testing were “at [the] higher side of the specification limit,” according to the February 24, 2021, US Food and Drug Administration (FDA) Enforcement Report. 

The latest recall affects the following cephalexin products, which were manufactured by Alkem Laboratories and distributed by Ascend Laboratories throughout the United States:

• 14,205 100-mL bottles of cephalexin for oral suspension, 250 mg/5 mL (NDC 67877-545-88), from lots 19144841 (Exp. 9/21) and 20141673 (Exp. 4/22); and
• 23,436 200-mL bottles of cephalexin for oral suspension, 250 mg/5 mL (NDC 67877-545-68), from lots 19141869 and 19141870 (Exp. 3/21), 19142762 (Exp. 5/21), and 19143826, 19143923,19143941, and 19143954 (Exp. 7/21). 

Ascend Laboratories voluntarily initiated the recall January 22, 2021. On February 18, 2021, the FDA designated the recall Class II, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm. 

Similar cephalexin recalls initiated by Ascend Laboratories were announced in the January 6, 2021, and the January 13, 2021, FDA Enforcement Reports. 

Cephalexin is a prescription cephalosporin antibiotic used to treat a wide variety of bacterial infections. 

—Jolynn Tumolo