PlainRecalls
FDA Drug Moderate Class II Terminated

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

Reported: June 12, 2013 Initiated: May 16, 2013 #D-501-2013

Product Description

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

Reason for Recall

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

Details

Recalling Firm
Hospira Inc.
Units Affected
95,700 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 fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12. Recalled by Hospira Inc.. Units affected: 95,700 vials.
Why was this product recalled?
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 12, 2013. Severity: Moderate. Recall number: D-501-2013.