PlainRecalls
FDA Drug Moderate Class II Terminated

Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30

Reported: February 4, 2015 Initiated: December 23, 2014 #D-0381-2015

Product Description

Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30

Reason for Recall

Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.

Details

Recalling Firm
Hospira Inc.
Units Affected
126,075 vials
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. Recalled by Hospira Inc.. Units affected: 126,075 vials.
Why was this product recalled?
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 4, 2015. Severity: Moderate. Recall number: D-0381-2015.