FDA-Drug2016-06-08Class III
Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.
Lupin Pharmaceuticals Inc.
Hazard
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Sold states
Nationwide and Puerto Rico
Affected count
741.171 kg
Manufactured in
111 S Calvert St Fl 21ST, N/A, Baltimore, MD, United States
Products
Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0955-2016Don't want to check this manually?
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