Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-4699-30
Reported: September 18, 2013 Initiated: August 14, 2013 #D-932-2013
Product Description
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-4699-30
Reason for Recall
Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 283,150 vials
- Distribution
- Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-4699-30. Recalled by Hospira Inc.. Units affected: 283,150 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 18, 2013. Severity: Moderate. Recall number: D-932-2013.
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