PlainRecalls
FDA Drug Moderate Class II Terminated

Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02

Reported: March 12, 2014 Initiated: February 10, 2014 #D-1147-2014

Product Description

Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02

Reason for Recall

Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.

Details

Recalling Firm
Hospira Inc.
Units Affected
115,500 Vials
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02. Recalled by Hospira Inc.. Units affected: 115,500 Vials.
Why was this product recalled?
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 12, 2014. Severity: Moderate. Recall number: D-1147-2014.