FDA-Drug2019-01-16Class I
Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.
Lupin Pharmaceuticals Inc.
Hazard
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Sold states
Nationwide in the USA and Puerto Rico.
Affected count
3,792 boxes
Manufactured in
111 S Calvert St Fl 21ST, Baltimore, MD, United States
Products
Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0358-2019Don't want to check this manually?
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