Propofol Injectable 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.

FDA recall notice · announced November 13, 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 packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.

Reason for recall

Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.

Notes

Distribution: Nationwide
Lot/code information: Lot #: 27-570-DJ, Exp 03/01/15
Quantity: 70,450 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 packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. (D-66637-001)

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