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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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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Similar recalls
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