D-0358-2019 Class I Terminated
FDA drug recall D-0358-2019 was initiated by Lupin Pharmaceuticals Inc. on December 20, 2018 and is designated Class I. 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. The recall status is terminated (terminated August 18, 2020). Affected quantity: 3,792 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- January 16, 2019
- Initiation Date
- December 20, 2018
- Termination Date
- August 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,792 boxes
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lot #: C600109, Exp 05/19; C600129, C600135, Exp 08/19