Recalls / Class II
Class IID-597-2013
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)
- Affected lot / code info
- Lot #: DB2208, Exp 01/16
Why it was 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.
Recalling firm
- Firm
- Sandoz Incorporated
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2555 W Midway Blvd, N/A, Broomfield, Colorado 80020-1632
Distribution
- Quantity
- 297,200 vials
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2013-05-30
- FDA classified
- 2013-06-11
- Posted by FDA
- 2013-06-19
- Terminated
- 2014-07-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-597-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.