Elevated risk U.S. Food and Drug Administration

Hospira Propofol Injection Emulsion, USP recall: Potential presence of visible particulate

Recall published 4+ years ago

Potential presence of visible particulate

Hospira Prescription & OTC drugs — recalled prescription & otc drugsHospira Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Sterility or particulate concern

This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

What the notice says: Potential presence of visible particulate

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
August 22, 2022
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Hospira
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Propofol Injection Emulsion, USP

What the company announced

FOR IMMEDIATE RELEASE -NEW YORK, NY., August 22, 2022 Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial; lot EA7470, to the user level due to visible particulates observed in two vials during annual examination of retention samples.

Risk Statement: Patients receiving the impacted product have a remote probability of experiencing potential adverse events, such as blockage of blood vessels, including decreased blood flow to the brain, heart attack, pulmonary embolus, and tissue necrosis. Hypersensitivity reactions and transmission of infectious disease can also occur.

To date, Pfizer has not received reports of any adverse events associated with this issue for this lot.

Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Propofol Injectable Emulsion is a terminally sterilized (TS) product. It is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration supplied in a Single Patient Use Glass Fliptop Vial.

The NDC, Lot Number, Expiration Date, and Configuration details for Propofol Injectable Emulsion are indicated below. The product lot was distributed nationwide to wholesalers/hospitals in the United States from July 16, 2020 through July 24, 2020.

  • Product: Propofol Injectable Emulsion, 100 mL Single Patient Use Glass Fliptop Vial · NDC: Vial: 0409-4699-54 Tray: 0409-4699-24 · Lot Number: EA7470 · Expiration Date: 01 JUNE 2023 · Presentation: 1g/100 mL, Single Patient Use Glass Fliptop Vial · Configuration/ Count: Tray of 10 Units

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers or hospitals with an existing inventory of the lot, which is being recalled, should discontinue use, stop distribution and quarantine immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. For additional assistance, call Sedgwick Inc. at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.

  • Contact Center: Pfizer Medical Information · Contact Information: 1-800-438-1985, option 3 (8am to 9pm ET Monday through Friday) www.pfizermedinfo.com · Area of Support: For medical questions regarding the product
  • Contact Center: Pfizer Drug Safety · Contact Information: 1-800-438-1985, option 1 (24 hours a day; 7 days a week) · Area of Support: To report adverse events and product complaints

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • EA7470

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 01 JUNE 2023

Model or item number

On the rating label, the box or the instruction sheet.

  • 100

Package size

Match the net weight or the piece count on the front of the pack.

  • 100 mL
  • 10 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Hospira — This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Report any infection or reaction you think the product caused to FDA MedWatch.
  3. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  4. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Hospira, Inc., a Pfizer Company — Consumers: Sedgwick Inc, 1-800-805-3093 — Media: Media Relations, 1-212-733-7410, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Hospira prescription & otc drugs recalled?

Potential presence of visible particulate Potential presence of visible particulate

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code EA7470; best-by date 01 JUNE 2023; model number 100. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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