Hospira Recalls Propofol Injectable Emulsion Due to Particulate Matter
Hospira Inc. is recalling 148,630 vials of Propofol Injectable Emulsion because a single visible particulate was found in sample bottles during 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 hazard involves a single visible particulate in a sterile injectable product, which poses a potential risk but is not associated with reported serious injuries or deaths in the source text.
Plain-English summary
Hospira Inc. is recalling 148,630 vials of Propofol Injectable Emulsion, 1%, in 20 mL, 50 mL, and 100 mL single-patient infusion vials. The product is distributed nationwide and is available by prescription only.
The recall was initiated because a single visible particulate was observed and confirmed in sample bottles of the affected lots during a retain inspection. The specific lot numbers and expiration dates are listed in the recall documentation.
Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions or replacement.
The recalled product
- Product
- PROPOFOL (PROPOFOL)
- Brand
- PROPOFOL
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Affected units
- 148,630
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 (13)
- Lot No: a) 93-857-DJ
- 93-896-DJ
- Exp 1SEP2012
- 04-515-DJ
- Exp 1APR2013
- 06-802-DJ
- Exp 1JUN2013
- b) 01-175-DJ
- Exp 1JAN2013
- 04-565-DJ
- c) 03-388-DJ
- Exp 1MAR2013
- The lot number may be followed by 01 or 02
Distribution
Distributed nationwide across the United States.
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