Hospira Recalls Propofol Injectable Emulsion Due to Visible Particulate Matter
Hospira Inc. is recalling 283,150 vials of Propofol Injectable Emulsion because visible particulate matter was found embedded in the glass vials 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 the hazard involves visible particulate matter in a drug product, which poses a potential risk but does not meet the criteria for Severe or Critical severity as no injuries or deaths are reported.
Plain-English summary
Hospira Inc. is recalling 283,150 vials of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL). The product is packaged in 5 Units x 20 mL Single patient infusion vials per carton and is available by prescription only. The affected lots are 24-461-DJ*, 26-543-DJ*, 27-555-DJ*, and 27-559-DJ*, with expiration dates ranging from 12/14 to 03/15. The lot numbers may be followed by 01.
The recall was initiated because visible particulate matter was observed and confirmed to be embedded in the glass vial during a retain sample inspection. The product was distributed nationwide.
Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions. Consumers should not use the product if they notice any visible particulate matter in the vials.
The recalled product
- Product
- PROPOFOL (PROPOFOL)
- Brand
- PROPOFOL
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 283,150
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 #: 24-461-DJ*
- Exp 12/14
- 26-543-DJ*
- Exp 02/15
- 27-555-DJ*
- 27-559-DJ*
- Exp 03/15
- *lot number may be followed by 01
Distribution
Distributed nationwide across the United States.
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Similar recalls
- ModerateHospira Recalls Propofol Injectable Emulsion Due to Particulate Matter
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