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.
Reported: April 3, 2013 Initiated: February 25, 2013 #D-223-2013
Product Description
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 for Recall
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 68,020 vials
- Distribution
- Nationwide.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hospira Inc.. Units affected: 68,020 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 3, 2013. Severity: Moderate. Recall number: D-223-2013.
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