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Recall Observatory FDA recall evidence

Drug product

Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box)

D-597-2013

May 30, 2013

Class II

Product summary

Firm
Sandoz Incorporated
Event
Event 65318
Status
Terminated
Classification
Class II
Quantity
297,200 vials
Official record key
drug-enforcement:D-597-2013

Official wording

Reason: Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.

Code information: Lot #: DB2208, Exp 01/16

Distribution pattern: Nationwide and Puerto Rico.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility