Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary recall of one lot of 1% Lidocaine HCI Injection, USP to the user level due to a confirmed customer report of orange and black particulate within the solution and embedded within the glass vial. Hospira has identified the particulate as iron oxide. Risk factors associated with the particulate include the potential for particulate to be injected and/or a delay in therapy.
If the particulate or smaller pieces of the particulate that could break off, become free floating within the solution pass through the catheter into the patient, it may result in local inflammation, and/or mechanical disruption of tissue or immune response to the particulate. Chronically, following sequestration, local granuloma formulation may occur.
This lot was distributed nationwide to distributors/wholesalers, hospitals and clinics from September 2013 through October 2013. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. The lot number affected by the recall is:
If the particulate or smaller pieces of the particulate that could break off, become free floating within the solution pass through the catheter into the patient, it may result in local inflammation, and/or mechanical disruption of tissue or immune response to the particulate. Chronically, following sequestration, local granuloma formulation may occur.
This lot was distributed nationwide to distributors/wholesalers, hospitals and clinics from September 2013 through October 2013. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. The lot number affected by the recall is:
Product
|
NDC Number
|
Lot
|
Expiration Date
|
|---|---|---|---|
| 1% Lidocaine HCI Injection, USP, 10mg/mL, 30 mL single dose, Preservative - Free |
0409-4279-02
|
31-427-DK
|
1JUL2015
|
Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.
http://www.fda.gov/Safety/Recalls/ucm394020.htm
