FDA-Drug2016-06-08Class III
Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Lupin Pharmaceuticals Inc.
Hazard
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Sold states
Nationwide and Puerto Rico
Affected count
7908 vials
Manufactured in
111 S Calvert St Fl 21ST, N/A, Baltimore, MD, United States
Products
Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0952-2016Don't want to check this manually?
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