FDA-Drug2015-02-04Class II

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

Hospira Inc.
Hazard

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

Sold states
Nationwide
Affected count
126,075 vials
Manufactured in
375 N Field Dr, N/A, Lake Forest, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0381-2015

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