Hospira Recalls Propofol Injectable Emulsion Due to Visible Particulate Matter
Hospira Inc. is recalling 68,020 vials of Propofol Injectable Emulsion, 1%, due to the presence of visible particulate matter.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (injectable drug) where the hazard is particulate matter, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Hospira Inc. is recalling 68,020 vials of Propofol Injectable Emulsion, 1%, packaged in single-patient infusion vials. The recall is being conducted because visible particulate matter was observed and confirmed in a sample bottle during a retain inspection.
The affected product is distributed nationwide. The specific lots involved are 06-804-DJ* (expiration 1JUN2013), 05-736-DJ* (expiration 1MAY2013), and 09-066-DJ* (expiration 1SEP2013). The lot numbers may be followed by 01 or 02. The product is available in two configurations: 5 x 20 mL vials per carton (NDC 0409-4699-30) and 10 x 100 mL vials per carton (NDC 0409-4699-24).
Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions. This recall is classified as FDA Class II.
The recalled product
- Product
- PROPOFOL (PROPOFOL)
- Brand
- PROPOFOL
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 68,020
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 (6)
- a) Lot #: 06-804-DJ*
- Exp 1JUN2013
- and b) Lot #: 05-736-DJ*
- Exp 1MAY2013
- 09-066-DJ*
- Exp 1SEP2013. *Note: the lot number may be followed by 01 or 02.
Distribution
Distributed nationwide across the United States.
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