PlainRecalls
FDA Drug Moderate Class II Terminated

Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24

Reported: September 5, 2012 Initiated: August 3, 2012 #D-1672-2012

Product Description

Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24

Reason for Recall

Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.

Details

Recalling Firm
Hospira Inc.
Units Affected
56,420 vials
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24. Recalled by Hospira Inc.. Units affected: 56,420 vials.
Why was this product recalled?
Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 5, 2012. Severity: Moderate. Recall number: D-1672-2012.