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.

Recall Number: D-0358-2019

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, 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.