The Recall Desk
SevereFDA (Drugs)·D-1382-2012·Announced 2012-06-20

Hospira Recalls Propofol Injectable Emulsion Due to Particulate Matter

Hospira, Inc. is recalling specific lots of Propofol Injectable Emulsion because a single visible particulate was observed in a retention sample.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a drug with potential for adverse health consequences (particulate matter in an IV drug) falls under the 'Severe' category, particularly given the structural/quality defect nature of the issue.

Plain-English summary

Hospira, Inc. is voluntarily recalling specific lots of Propofol Injectable Emulsion, 1% (10mg/mL). The recall involves 20 mL and 100 mL single-patient infusion vials distributed nationwide. The specific lots affected are 03440DJ (with expiration 1MAR2013), 07947DJ (with expiration 1JUL2013), and 10134DJ (with expiration 1OCT2013). Note that lot 03440DJ may be followed by 01.

The recall was initiated because a single visible particulate was observed in a retention sample bottle identified as stainless steel. This finding indicates the presence of particulate matter in the product. The FDA has classified this recall as Class II, which means there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and facilities should check their inventory for the specific lot numbers and expiration dates listed above. If these products are found, they should be removed from use and returned to Hospira, Inc. or the distributor. Patients who have received these specific lots should contact their healthcare provider if they have any concerns or experience adverse effects.

The recalled product

Product
PROPOFOL (PROPOFOL)
Brand
PROPOFOL
Manufacturer
Hospira, Inc.
Category
Drug — Injectable Anesthetic
Hazard

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 (7)

  • Lot #: a) 03440DJ*
  • Exp 1MAR2013
  • b) 07947DJ
  • Exp 1JUL2013
  • 10134DJ
  • Exp 1OCT2013
  • Note: * the lot may be followed by 01.

Distribution

Distributed nationwide across the United States.

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Same hazard · particulate matter

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