PlainRecalls
FDA Drug Moderate Class II Terminated

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

Reported: November 13, 2013 Initiated: October 11, 2013 #D-66637-001

Product Description

Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

Reason for Recall

Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.

Details

Recalling Firm
Hospira Inc.
Units Affected
70,450 vials
Distribution
Nationwide
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 packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.. Recalled by Hospira Inc.. Units affected: 70,450 vials.
Why was this product recalled?
Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 13, 2013. Severity: Moderate. Recall number: D-66637-001.