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.

FDA recall notice · announced February 11, 2015 · Hospira

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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.

Notes

Distribution: Nationwide.
Lot/code information: Lot number: 31-427-DK, Exp 01JUL2015.
Quantity: 120,900 vials
Status: Terminated
Products in this recall event:
- 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. (D-0382-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.