Lupin Pharmaceuticals Inc. recalls Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only
Recalled January 16, 2019 · FDA recall D-0375-2019 · Lupin Pharmaceuticals
Hazard
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick. · FDA Class II
Units
287,784 bottles
Sold at
Nationwide within the United States
Description
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Product
Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →