# FDA recall D-597-2013

> **Sandoz Incorporated** · Class II · drug recall initiated 2013-05-30.

## 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)

## 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.

## Distribution

Nationwide and Puerto Rico.

## Key facts

- **Recall number:** D-597-2013
- **Recalling firm:** Sandoz Incorporated
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-05-30
- **Report date:** 2013-06-19
- **Termination date:** 2014-07-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Broomfield, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-597-2013

## Citation

> AI Analytics. FDA recall D-597-2013. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-597-2013. Source: US FDA. Licensed CC0.

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