Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24

FDA recall notice · announced September 5, 2012 · Hospira

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

The product

Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24

Reason for recall

Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.

Notes

Distribution: Nationwide
Lot/code information: 07-893-DJ, exp. 7/2013, 10-123-DJ, 10-125-DJ, exp. 10/2013
Quantity: 56,420 vials
Status: Terminated
Products in this recall event:
- Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24 (D-1672-2012)

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