May 01, 2020
Concerns over drug subpotency have prompted Lupin Pharmaceuticals Inc. to voluntarily recall 4518 bottles of cefixime for oral suspension, 100 mg/5 mL. According to the April 29, 2020, US Food and Drug Administration (FDA) Enforcement Report, a long-term stability test of the drug revealed low, out-of-specification results for potency.
The recall affects cefixime for oral suspension, 100 mg/5 mL (NDC 68180-405-01), from lot F800779 (Exp. 4/20). The product was distributed throughout the United States and in Puerto Rico.
Lupin Pharmaceuticals initiated the recall April 15, 2020. The FDA designated the recall Class II on April 23, 2020. Under Class II recalls, use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Cefixime is a prescription cephalosporin antibiotic used to treat bacterial infections.