FDA-Drug2019-01-16Class I
Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use 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
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
a) 8,000 vials; b) 32,045 boxes
Manufactured in
111 S Calvert St Fl 21ST, Baltimore, MD, United States
Products
Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use 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-0356-2019Don't want to check this manually?
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