Elevated risk U.S. Food and Drug Administration

Par Pharmaceutical Treprostinil 20mg/20mL Injection recall: Potential Presence of Silicone Particulate Matter

Recall published 2+ years ago

Potential Presence of Silicone Particulate Matter

Par Pharmaceutical Prescription & OTC drugs — recalled prescription & otc drugs
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Foreign material — foreign objects

Fragments of foreign objects may have got into this product during manufacture, which is why whole production codes are withdrawn rather than a handful of packs.

What the notice says: Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material.

Why it matters: Pieces of foreign objects may be inside the product. The risk here is physical rather than microbial: cuts to the mouth or throat, a broken tooth, or an injury further down if a fragment is swallowed.

Symptoms and when to call a doctor

If someone has swallowed a fragment and has mouth or throat pain, trouble swallowing, chest or stomach pain, vomiting, or blood in saliva or stool, they should be seen the same day. A fragment swallowed without symptoms usually passes on its own, but tell the clinician exactly what the product was: whether it shows up on imaging depends entirely on the material, so describe the product and the notice to them.

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
March 12, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Par Pharmaceutical
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Treprostinil 20mg/20mL Injection

What the company announced

FOR IMMEDIATE RELEASE – March 12, 2024 – DUBLIN, Ireland – Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product solution.

Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Par has not received any reports of adverse events related to this recall.

Treprostinil Injection is formulated for subcutaneous or intravenous infusion. The product is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise and for patients who require transition from epoprostenol to reduce the rate of clinical deterioration.

Treprostinil Injection 20mg/20mL (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01. Only Lot 57014, expiration date 04/2024 is affected by this recall. The lot was distributed nationwide to wholesalers and hospitals from June 16, 2022, through October 17, 2022.

Vials from the affected lot bear this label: [see below]

Par is providing written notification to wholesale accounts and the hospital location that have received the affected lot and is arranging for return of all existing inventory of Lot 57014 through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution immediately. If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.

For information regarding the recall process, call Inmar, Inc. at 1-855-410-3565 Monday through Friday between the hours of 9 am and 5 pm EST. For medical or technical product information or to report a product complaint or adverse event please call 1-800-828-9393.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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 6 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.

  • 57014

Best-by / use-by date

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

  • 04/2024

NDC number

On the carton and again on the bottle or blister label.

  • 42023-206-01

Package size

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

  • 20 mg
  • 20 mL
  • 1 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 Foreign material

Par Pharmaceutical — Fragments of foreign objects may have got into this product during manufacture, which is why whole production codes are withdrawn rather than a handful of packs.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. If someone has already bitten into something hard, have them stop, spit out what is in their mouth and rinse rather than swallow.
  3. Keep the pack if you can. If anyone was hurt, the fragment and the packaging together are the evidence that matters.
  4. Return it to the store or bin it sealed, and claim the refund using the lot code from the label.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Company contact: Endo International, Par Pharmaceutical — Consumers: Inmar, Inc., 1-855-410-3565 — Media: Linda Huss, [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 Par Pharmaceutical prescription & otc drugs recalled?

Potential Presence of Silicone Particulate Matter Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 57014; best-by date 04/2024. 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 eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.

Can I get my money back?

Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls