Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

FDA recall notice · announced May 1, 2013 · 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 (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

Reason for recall

Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: 11-185-DJ*, 11-196-DJ*, Exp 1NOV2013; * may be followed by 01 or 02
Quantity: 245,250 vials
Status: Terminated
Products in this recall event:
- Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. (D-297-2013)

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