The Recall Desk
CriticalFDA (Drugs)·D-1540-2022·Announced 2022-09-21

Propofol Injectable Emulsion Recalled for Particulate Matter Contamination

Pfizer is recalling 5,390 vials of Propofol Injectable Emulsion due to the presence of particulate matter. The affected lot (EA7470, expiration 6/1/2023) was distributed nationwide.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I drug recalls represent the most serious FDA classification, indicating products that could cause serious adverse health consequences or death. This classification inherently qualifies for Critical severity.

Plain-English summary

Pfizer Inc. is recalling Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass vials. The recall affects lot EA7470 with an expiration date of 6/1/2023, totaling 5,390 vials distributed nationwide in the United States.

The recall was initiated due to the presence of particulate matter in the product.

Healthcare providers and facilities that received affected vials should discontinue use immediately and contact Pfizer for replacement product or further recall instructions. Patients who received injections from affected vials should consult their healthcare provider.

The recalled product

Product
PROPOFOL (PROPOFOL)
Brand
PROPOFOL
Manufacturer
Pfizer Inc.
Category
Drug — Injectable Anesthetic
Hazard
Affected units
5,390

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 (2)

  • Lot#: EA7470
  • Exp 6/1/2023

Distribution

Distributed nationwide across the United States.

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Same hazard · particulate matter

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