Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33
Reported: August 21, 2013 Initiated: May 25, 2013 #D-887-2013
Product Description
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33
Reason for Recall
Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 94,110 vials
- Distribution
- Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33. Recalled by Hospira Inc.. Units affected: 94,110 vials.
Why was this product recalled? ▼
Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 21, 2013. Severity: Moderate. Recall number: D-887-2013.
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