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)
Reported: June 19, 2013 Initiated: May 30, 2013 #D-597-2013
Product Description
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)
Reason for Recall
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.
Details
- Recalling Firm
- Sandoz Incorporated
- Units Affected
- 297,200 vials
- Distribution
- Nationwide and Puerto Rico.
- Location
- Broomfield, CO
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Sandoz Incorporated. Units affected: 297,200 vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 19, 2013. Severity: Moderate. Recall number: D-597-2013.
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