Hospira Recalls Propofol Injectable Emulsion Vials Due to Particulate Matter
Hospira is recalling 94,110 vials of Propofol Injectable Emulsion because a single stainless steel particulate was found during inspection.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a single particulate matter finding without reported injuries, fitting the criteria for moderate severity.
Plain-English summary
Hospira, Inc. is recalling 94,110 vials of Propofol Injectable Emulsion, 1% and 500 mg/50 mL, single-patient infusion vials. The recall was initiated after a single visible particulate, identified as stainless steel, was found during a retain sample inspection.
The affected lots are 07-950-DJ (Exp. 1JUL2013), 10-101-DJ (Exp. 1OCT2013), and 10-102-DJ (Exp. 1OCT2013). The product was distributed nationwide. The FDA has classified this recall as Class II, meaning it is a violation of labeling or manufacturing standards that could cause temporary or medically reversible health consequences.
Healthcare providers and patients should stop using the affected vials and contact Hospira or their supplier for instructions on how to return the product.
The recalled product
- Product
- PROPOFOL (PROPOFOL)
- Brand
- PROPOFOL
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Affected units
- 94,110
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 (3)
- Lot 07-950-DJ Exp. Date 1JUL2013
- 10-101-DJ Exp. Date 1OCT2013
- and 10-102-DJ Exp. Date 1OCT2013
Distribution
Distributed nationwide across the United States.
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