PlainRecalls
FDA Drug Moderate Class II Terminated

Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12

Reported: September 4, 2013 Initiated: August 16, 2013 #D-927-2013

Product Description

Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12

Reason for Recall

Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.

Details

Recalling Firm
Hospira Inc.
Units Affected
72,300 vials
Distribution
Nationwide and Puerto Rico
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12. Recalled by Hospira Inc.. Units affected: 72,300 vials.
Why was this product recalled?
Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 4, 2013. Severity: Moderate. Recall number: D-927-2013.