PlainRecalls
FDA Drug Moderate Class II Terminated

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045

Reported: October 16, 2013 Initiated: September 5, 2013 #D-66295-001

Product Description

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045

Reason for Recall

Lack of Assurance of Sterility; potential for vial breakage

Details

Recalling Firm
Hospira Inc.
Units Affected
187,150 vials
Distribution
Nationwide and Guam and Abu Dhabi
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045. Recalled by Hospira Inc.. Units affected: 187,150 vials.
Why was this product recalled?
Lack of Assurance of Sterility; potential for vial breakage
Which agency issued this recall?
This recall was issued by the FDA Drug on October 16, 2013. Severity: Moderate. Recall number: D-66295-001.