Status
Terminated
Drug Enforcement D-597-2013
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.
Classification
Class II
Report Date
June 19, 2013
Termination Date
July 7, 2014
Product Information
- 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)
- Product quantity
- 297,200 vials
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico.
Location & Firm
- Recalling firm
- Sandoz Incorporated
- Address
-
2555 W Midway Blvd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-597-2013
- Event ID
- 65318
- Recall initiation date
- May 30, 2013
- Center classification date
- June 11, 2013
- Code info
- Lot #: DB2208, Exp 01/16
- More code info
- —