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, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33

Reported: August 21, 2013 Initiated: May 25, 2013 #D-887-2013

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, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33

Reason for Recall

Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel

Details

Recalling Firm
Hospira Inc.
Units Affected
94,110 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, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33. Recalled by Hospira Inc.. Units affected: 94,110 vials.
Why was this product recalled?
Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
Which agency issued this recall?
This recall was issued by the FDA Drug on August 21, 2013. Severity: Moderate. Recall number: D-887-2013.