FDAFDA · Food and drugs·Recall number D-0357-2019
Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Published January 16, 2019 · Recall initiated: December 20, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Nationwide in the USA and Puerto Rico.
- Lot
- Lot #: a) C600110, Exp 05/19; C600130, Exp 08/19; C700113, Exp 03/20; C700143, Exp 05/20; b) C600106, C600108, Exp 05/19; C600128, C600138, Exp 08/19; C600174, C600179, C600180, C600181, Exp 09/19; C700108, C700109, C700110, C700111, C700112, Exp 03/20; C700129, C700130, C700131, C700132, C700138, C700142, C700145, Exp 05/20
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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