Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, C...
FDA Recall #D-0381-2015 — Class II — December 23, 2014
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.
Recalling Firm
Hospira Inc. — Lake Forest, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
126,075 vials
Distribution
Nationwide
Code Information
Lot 35-844-DJ, Exp 11/01/2015
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated