November 15, 2019
Lupin Pharmaceuticals Inc. is recalling multiple lots of cefdinir for oral suspension after a dead ant was discovered in a bottle, according to the November 13, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall includes the following products, which were sent to major distributors and wholesalers throughout the United States:
- cefdinir for oral suspension, 125 mg/5 mL, 60-mL bottles (NDC 68180-722-20) from lot F900153 (Exp. 11/20), and 100-mL bottles (NDC 68180-722-10) from lots F802327, F802328, and F802329 (Exp. 11/20); and
- cefdinir for oral suspension, 250 mg/5 mL,100-mL bottles (NDC 68180-723-10) from lots F802345, F802346, and F802347 (Exp. 11/20).
Lupin Pharmaceuticals voluntarily initiated the recall November 1, 2019. The FDA designated the recall Class III on November 7, 2019. Under the recall classification, use of the affected products is not likely to cause harm.
Cefdinir is a prescription antibiotic used to treat bacterial infections such as bronchitis, pneumonia, and tonsillitis.