Class I · High risk
PROPOFOL Injectable Emulsion
Presence of particulate matter
Propofol Injectable Emulsion
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of particulate matter: particulate identified as a beetle.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
Affected NDCs
0409-4699-24
0409-4699-54
Compare with the code on your package — it is the most precise check available.
Drug: Propofol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Propofol NDC 00409-4699 |
10 mg/mL | Injection, Emulsion Intravenous |
Hospira, Inc. | Rx |
- Recalling firm
- Pfizer Inc.
- NDC code
- 0409-4699-54
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Aug 22, 2022 · FDA notice with lot numbers
- FDA recall number
- D-1301-2022 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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Class II · Moderate risk
Propofol Injectable Emulsion
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