Recall: D-223-2013

Class II - Potentially Harmful

Class IIClassification

2013-02-25Initiated

TerminatedStatus

Hospira Inc.Firm

Product

Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA.

Reason

Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.

Distribution

Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.