PlainRecalls
FDA Drug Moderate Class II Terminated

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

Reported: May 1, 2013 Initiated: April 8, 2013 #D-297-2013

Product Description

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

Reason for Recall

Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.

Details

Recalling Firm
Hospira Inc.
Units Affected
245,250 vials
Distribution
Nationwide and Puerto Rico
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.. Recalled by Hospira Inc.. Units affected: 245,250 vials.
Why was this product recalled?
Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 1, 2013. Severity: Moderate. Recall number: D-297-2013.