PlainRecalls
FDA Drug Critical Class I Terminated

Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29

Reported: October 8, 2014 Initiated: June 17, 2014 #D-0002-2015

Product Description

Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29

Reason for Recall

Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.

Details

Recalling Firm
Hospira Inc.
Units Affected
40,730 vials
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29. Recalled by Hospira Inc.. Units affected: 40,730 vials.
Why was this product recalled?
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 8, 2014. Severity: Critical. Recall number: D-0002-2015.