Drug product
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.
D-0358-2019
Product summary
- Event
- Event 81796
- Status
- Terminated
- Classification
- Class I
- Quantity
- 3,792 boxes
- Official record key
drug-enforcement:D-0358-2019
Official wording
Reason: Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
Code information: Lot #: C600109, Exp 05/19; C600129, C600135, Exp 08/19
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter