Hospira Recalls Propofol Injectable Emulsion Due to Particulate Matter
Hospira Inc. is recalling 273,925 vials of Propofol Injectable Emulsion because visible particulate matter was found 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 particulate matter in an injectable drug. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Hospira Inc. is recalling 273,925 vials of Propofol Injectable Emulsion, 1%, in 20 mL, 50 mL, and 100 mL single-patient infusion vials. The recall was initiated because visible particulate matter and particulate embedded in vials were observed during retain inspection.
The affected product is distributed nationwide. Specific lot numbers and expiration dates are listed in the recall notice, including lots expiring between November 2012 and October 2013. The product is a prescription-only intravenous medication used for general anesthesia.
Consumers and healthcare providers should stop using the affected vials and contact Hospira Inc. for further instructions or to arrange for return of the product.
The recalled product
- Product
- PROPOFOL (PROPOFOL)
- Brand
- PROPOFOL
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 273,925
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 (20)
- Lot #: a) 95-070-DJ
- Exp 11/01/12
- 04-584-DJ
- 04-652-DJ
- Exp 04/01/13
- 05-718-DJ
- Exp 05/01/13
- 06-815-DJ
- Exp 06/01/13
- b) 04-525-DJ
- 04-530-DJ
- 04-641-DJ-04-646-DJ
- c) 02-291-DJ
- Exp 02/01/13
- 05-725-DJ
- 05-732-DJ
- 07-925-DJ
- Exp 07/01/13
- 09-065-DJ
- Exp 09/01/13
Distribution
Distributed nationwide across the United States.
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