PlainRecalls
FDA Drug Critical Class I Terminated

Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.

Reported: March 26, 2014 Initiated: October 18, 2013 #D-1161-2014

Product Description

Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.

Reason for Recall

Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.

Details

Recalling Firm
Hospira Inc.
Units Affected
40,360 vials
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.. Recalled by Hospira Inc.. Units affected: 40,360 vials.
Why was this product recalled?
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 26, 2014. Severity: Critical. Recall number: D-1161-2014.