D-0355-2019 Class I Terminated
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
- a) 12,000 vials; b) 11,763 boxes
Product Description
Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); 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.
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lot #: a) C600142, Exp 08/19; b) C600136, Exp 08/19; C600182, Exp 09/19, C700147, Exp 05/20; C700207, Exp 09/20 Additional lots added 12/19/2018 - C600142, C700147 and C700207