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
Product summary
- 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
Lack of Assurance of Sterility