Hospira Recalls Propofol Injectable Vials Due to Particulate Matter
Hospira Inc. is recalling 245,250 vials of Propofol Injectable Emulsion because a single visible particulate was found during a retain sample inspection.
What this means for you
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 source text explicitly states that a single visible particulate was identified during a retain sample inspection without reporting any illnesses or injuries, fitting the criteria for a moderate severity recall.
Plain-English summary
Hospira Inc. is recalling 245,250 vials of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial. The recall was initiated after a single visible particulate was identified during a retain sample inspection. The affected product is identified by Lot numbers 11-185-DJ* and 11-196-DJ*, with an expiration date of 1NOV2013. The asterisk in the lot number may be followed by 01 or 02.
The product was distributed nationwide and in Puerto Rico. This recall is classified as FDA Class II by the U.S. Food and Drug Administration. The source text does not report any illnesses or injuries associated with this recall.
Healthcare providers and facilities should stop using the affected vials and contact Hospira Inc. for further instructions. Consumers should not use the product and should contact their healthcare provider if they have questions.
The recalled product
- Product
- PROPOFOL (PROPOFOL)
- Brand
- PROPOFOL
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 245,250
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 (4)
- Lot #: 11-185-DJ*
- 11-196-DJ*
- Exp 1NOV2013
- * may be followed by 01 or 02
Distribution
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