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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Propofol Injectable Emulsion Recalled for Particulate Matter

Agency Publication Date: September 13, 2022
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Summary

Pfizer Inc. is recalling 5,390 vials of Propofol Injectable Emulsion (1 g/100 mL) due to the presence of visible particulate matter found in the solution. This recall affects medication packaged in 100 mL glass fliptop vials distributed by Hospira, Inc. No incidents or injuries have been reported to date. Healthcare providers and medical facilities should check their inventory for lot number EA7470 with an expiration date of June 1, 2023.

Risk

Injecting a drug containing particulate matter can cause serious health complications, such as blood clots, inflammation of the veins, or damage to vital organs like the lungs and heart.

What You Should Do

  1. This recall affects Propofol Injectable Emulsion (1 g/100 mL) packaged in 100 mL glass fliptop vials (NDC 0409-4699-54) or trays of 10 vials (NDC 0409-4699-24), identifying as lot number EA7470 with an expiration date of June 1, 2023.
  2. Stop using the recalled product. Contact Pfizer Inc. or your distributor to arrange return of the affected vials.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

๐Ÿ“‹Other Action

Hospital-administered medication return

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: PROPOFOL Injectable Emulsion (1 g/100 mL)
Variants: 10 mg/mL, 100 mL glass fliptop vial
Lot Numbers:
EA7470 (Exp 6/1/2023)
NDC:
0409-4699-54
0409-4699-24

Distributed by Hospira, Inc.

Product Images

Image Front Label: Propofol Injection Emulsion, 1g/100 mL (10mg/mL)

Image Front Label: Propofol Injection Emulsion, 1g/100 mL (10mg/mL)

Image Side Label:  Coding โ€“ L EA7470 EXP.: 01 JUN 2023

Image Side Label: Coding โ€“ L EA7470 EXP.: 01 JUN 2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90785
Status: Resolved
Manufacturer: Pfizer Inc.
Sold By: Hospira, Inc.
Manufactured In: United States
Units Affected: 5,390 vials
Distributed To: Nationwide
Agency Last Updated: September 19, 2022

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.