FDA Recall D-0357-2019

Lupin Pharmaceuticals Inc. · Baltimore, MD

Class I — life-threatening Terminated 607 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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.

Lot / code: 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

Quantity: a) 35,000 vials; b) 112,641 boxes

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.

Recall record

Recall number: D-0357-2019
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA and Puerto Rico.
Recall initiated: 2018-12-20
Classified by FDA Center: 2019-01-14
FDA published: 2019-01-16
Terminated: 2020-08-18
Recalling firm: Lupin Pharmaceuticals Inc.
Firm location: Baltimore, MD

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