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.

Recall Number: D-0356-2019

Firm: Lupin Pharmaceuticals Inc.

Classification: Class I

Status: Terminated

Report Date: 20190116

Initiation Date: 20181220

Termination Date: 20200818

Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.

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.