Product: 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.
Reason for recall: Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Recall initiated: 20181220
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated