PlainRecalls
FDA Drug Critical Class I Terminated

1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.

Reported: February 11, 2015 Initiated: April 18, 2014 #D-0382-2015

Product Description

1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.

Reason for Recall

Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.

Details

Recalling Firm
Hospira Inc.
Units Affected
120,900 vials
Distribution
Nationwide.
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-dose vials, packaged in 25-count cartons, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4279-02.. Recalled by Hospira Inc.. Units affected: 120,900 vials.
Why was this product recalled?
Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 11, 2015. Severity: Critical. Recall number: D-0382-2015.