April 22, 2021
Lupin Pharmaceuticals Inc is recalling three lots of cefprozil for oral suspension because of superpotency, according to the April 21, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, which were manufactured by Lupin Limited, Mandideep, India, for Lupin Pharmaceuticals Inc., Baltimore, Maryland, and distributed in the United States and Puerto Rico:
- cefprozil for oral suspension 50-mL (when mixed) bottles (NDC 68180-402-01) from lot F801122 (Exp. 6/21);
- cefprozil for oral suspension 75-mL (when mixed) bottles (NDC 68180-402-02) from lot F801123 (Exp. 6/21); and
- cefprozil for oral suspension 100-mL (when mixed) bottles (NDC 68180-402-03) from lot F801124 (Exp. 6/21).
Lupin Pharmaceuticals Inc. voluntarily initiated the recall March 26, 2021. On April 12, 2021, the FDA designated the recall Class II, suggesting use of the recalled product may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
Cefprozil is a prescription antibiotic used to treat a variety of bacterial infections.