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

FDA recall notice · announced February 4, 2015 · Hospira

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide
Lot/code information: Lot 35-844-DJ, Exp 11/01/2015
Quantity: 126,075 vials
Status: Terminated
Products in this recall event:
- 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 (D-0381-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.