Skip to content
Recall Observatory FDA recall evidence

Drug product

Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

D-0356-2019

December 20, 2018

Class I

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 81796
Status
Terminated
Classification
Class I
Quantity
a) 8,000 vials; b) 32,045 boxes
Official record key
drug-enforcement:D-0356-2019

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 #: a) C600173, Exp 08/19; C600218, Exp 09/19; b) C600126, C600127, C600137, C600143, Exp 08/19; C600219, Exp 09/19; C700146, Exp 05/20; C700208, C700209, Exp 09/20.

Distribution pattern: Nationwide in the USA and Puerto Rico.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Particulate Matter