Drug product
Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
D-1033-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 67322
- Status
- Terminated
- Classification
- Class II
- Quantity
- 126,425 vials
- Official record key
drug-enforcement:D-1033-2014
Official wording
Reason: Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.
Code information: Lot #: 27-568-DJ*, Exp 03/15, Note * may be followed by 01
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter