May 2013 FDA Recall Drug by Sandoz Incorporated
D-597-2013 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Sandoz Incorporated on May 30, 2013 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-597-2013

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.
Initiated
05-30-2013
Reported
06-19-2013
Quantity
297,200 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65318
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sandoz Incorporated
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-07-2014
Product Description About Product Description
Full technical description of the 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)

Batch or Lot Expiration Information

Lot# : DB2208, Exp 01/16