Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, R...
FDA Recall #D-0358-2019 — Class I — December 20, 2018
Product Description
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.
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.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
3,792 boxes
Distribution
Nationwide in the USA and Puerto Rico.
Code Information
Lot #: C600109, Exp 05/19; C600129, C600135, Exp 08/19
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated