Hospira Recalls Propofol Vials Due to Metallic Particulate Matter
Hospira Inc. is recalling 844,300 vials of Propofol Injectable Emulsion because glass defects allowed metallic particulates to enter the solution.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The presence of metallic particulates in an intravenous drug is a significant hazard.
Plain-English summary
Hospira Inc. is recalling 844,300 vials of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration. The affected product is identified by NDC 0409-4699-30 and includes lot numbers 29-614-DJ, 29-615-DJ, 29-616-DJ, 29-617-DJ, 29-628-DJ, 29-629-DJ, and 29-630-DJ, all with an expiration date of 05/01/2015. The product was distributed nationwide.
The recall was initiated after a glass defect was discovered on the interior neck of a vial during a retain sample inspection. This defect resulted in visible embedded metallic particulate and free-floating metallic particulates being found in the solution. The presence of particulate matter in an intravenous medication poses a risk of harm to patients.
Healthcare providers and facilities should stop using the affected vials immediately and contact Hospira Inc. for further instructions on the return or destruction of the product. Patients who have received the affected medication should contact their healthcare provider if they experience any adverse effects.
The recalled product
- Product
- PROPOFOL (PROPOFOL)
- Brand
- PROPOFOL
- Manufacturer
- Hospira Inc.
- Category
- Drug — General Anesthetic
- Affected units
- 844,300
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #s: 29-614-DJ
- 29-615-DJ
- 29-616-DJ
- 29-617-DJ
- 29-628-DJ
- 29-629-DJ
- 29-630-DJ
- Exp 05/01/2015
Distribution
Distributed nationwide across the United States.
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