Class I · High risk
Propofol Injectable Emulsion
Presence of particulate matter: particulate identified as a beetle.
PROPOFOL Injectable Emulsion
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Presence of particulate matter
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 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
- FDA recall number
- D-1540-2022 · 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.
Other Propofol recalls
See all
Class II · Moderate risk
Diprivan (Propofol)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Diprivan (Propofol)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Propofol Injectable Emulsion
cGMP deviations: Temperature abuse
Class II · Moderate risk
Propofol Injectable Emulsion
cGMP deviations: Temperature abuse
Other recalls by Pfizer Inc.
All 2022 recalls
Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
Class II · Moderate risk
Vial Label: 8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Vial Label: Epinephrine Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Levoxyl (levothyroxine sodium tablets, USP)
Subpotent drug
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.