Date: 01/02/2019
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
Company: Lupin Pharmaceuticals Inc.
Recall Reason: CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Classification: Class II
Report Date: 20190116