Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30
Reported: August 27, 2014 Initiated: April 2, 2014 #D-1547-2014
Product Description
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30
Reason for Recall
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 844,300 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), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30. Recalled by Hospira Inc.. Units affected: 844,300 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 27, 2014. Severity: Critical. Recall number: D-1547-2014.
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