Drug 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
D-0381-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 70179
- Status
- Terminated
- Classification
- Class II
- Quantity
- 126,075 vials
- Official record key
drug-enforcement:D-0381-2015
Official wording
Reason: Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Code information: Lot 35-844-DJ, Exp 11/01/2015
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter