July 29, 2020
Lupin Pharmaceuticals Inc. is voluntarily recalling two lots of cefdinir for oral suspension after an assay test of retention samples indicated superpotency, according to the July 29, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects cefdinir for oral suspension, 250 mg/5 mL, packaged in 60-mL bottles (NDC 68180-723-20) from lots F802189 (Exp. 10/20) and F900240 (Exp. 1/21). The bottles were distributed throughout the United States.
Lupin Pharmaceuticals initiated the recall July 2, 2020. The FDA designated the recall Class II on July 23, 2020. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Cefdinir is a prescription cephalosporin antibiotic used to treat bacterial infections.