FDA-Drug2019-01-16Class II
Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Lupin Pharmaceuticals Inc.
Hazard
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Sold states
Nationwide within the United States
Affected count
287,784 bottles
Manufactured in
111 S Calvert St Fl 21ST, Baltimore, MD, United States
Products
Cefdinir for Oral Suspension USP, 250mg/5mL, packaged in a) 60mL (NDC 68180-723-20), b)100mL (NDC 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0376-2019Don't want to check this manually?
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