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
Reason for recall: CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Recall initiated: 20190102
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated