The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-297-2013·Announced 2013-05-01

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.

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 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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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