Medications & Supplements/Prescription Drugs

Pfizer Propofol Injectable Emulsion Recalled for Beetle Particulate

Agency Publication Date: July 26, 2022

Summary

Pfizer Inc. is recalling 54,000 vials of Propofol Injectable Emulsion, a prescription medication used to provide anesthesia and sedation. This recall was initiated after a beetle was identified as foreign particulate matter inside a single glass fliptop vial from the affected lot. No incidents or injuries related to this issue have been reported to date.

Risk

Injecting medication that contains foreign particulate matter, such as an insect, can cause serious health risks including inflammation of the blood vessels (phlebitis), lung damage, or severe allergic reactions.

What You Should Do

This recall affects Propofol Injectable Emulsion (1 g/100 mL) distributed by Hospira, Inc., identified by lot number DX9067 with an expiration date of 5/1/2023.
Identify affected products by looking for NDC 0409-4699-54 on individual 100 mL glass fliptop vials or NDC 0409-4699-24 on the 10-vial tray cartons.
Stop using the recalled product immediately and isolate any remaining inventory to prevent further use.
Contact Pfizer Inc. or your designated distributor to arrange for the return of any unused medication from this specific lot.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for further assistance or to report any adverse events.

Your Remedy Options

Other Action

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, 10-vial tray

Lot Numbers:

DX9067 (Exp 5/1/2023)

NDC:

0409-4699-54

0409-4699-24

Distributed by Hospira, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90581

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Hospira, Inc.; pharmacies; hospitals

Manufactured In: United States

Units Affected: 54,000 vials

Distributed To: Nationwide

Agency Last Updated: August 3, 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 · 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.

Summary

What You Should Do

This recall affects Propofol Injectable Emulsion (1 g/100 mL) distributed by Hospira, Inc., identified by lot number DX9067 with an expiration date of 5/1/2023.

Identify affected products by looking for NDC 0409-4699-54 on individual 100 mL glass fliptop vials or NDC 0409-4699-24 on the 10-vial tray cartons.

Stop using the recalled product immediately and isolate any remaining inventory to prevent further use.

Contact Pfizer Inc. or your designated distributor to arrange for the return of any unused medication from this specific lot.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for further assistance or to report any adverse events.