Propofol Injectable Emulsion Vials Recalled for Particulate Matter Contamination
Pfizer is recalling 54,000 vials of Propofol Injectable Emulsion (Lot DX9067) due to presence of particulate matter identified as a beetle. No illnesses or injuries have been reported.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this recall as Class I, which requires a minimum severity score of 4. Although no illnesses or injuries have been reported, contamination of an injectable anesthetic with confirmed foreign material (beetle) represents a serious potential risk of harm.
Plain-English summary
Pfizer Inc. has issued a Class I recall of Propofol Injectable Emulsion (10 mg/mL) due to the presence of particulate matter identified as a beetle in certain vials. The recalled product consists of 54,000 vials in Lot DX9067, with an expiration date of May 1, 2023, distributed nationwide throughout the USA.
Propofol is an intravenous anesthetic administered in medical and surgical settings. Contamination by foreign material in an injectable product presents a risk if administered to patients.
No illnesses or injuries related to this contamination have been reported to date. Healthcare providers and facilities in possession of affected vials from Lot DX9067 should cease use immediately and contact Pfizer or the FDA.
The recalled product
- Product
- PROPOFOL (PROPOFOL)
- Brand
- PROPOFOL
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Anesthetic Injectable
- Affected units
- 54,000
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 #: DX9067
- Exp 5/1/2023
Distribution
Distributed nationwide across the United States.
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