Par Pharmaceutical Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection Due to Potential for Silicone Particulates in the Product Solution

Rhea-AI Summary

Endo International plc's Par Pharmaceutical, Inc. is recalling a lot of Treprostinil Injection due to potential silicone particulates, with risks of local irritation, swelling, and serious health issues. The recall affects Lot 57014, distributed nationwide from June to October 2022.

Positive

• Endo International plc's swift action in voluntarily recalling the affected product to ensure consumer safety.
• Par Pharmaceutical, Inc. has not received any adverse event reports related to the recall, indicating proactive monitoring.
• Clear instructions provided for wholesalers and hospitals to discontinue use and return the affected lot, showcasing responsible handling of the situation.
• Detailed information on the product, recall process, and contact details for consumer queries or adverse event reporting, promoting transparency and accountability.

Negative

• The presence of silicone particulates in the product may raise concerns about quality control measures during manufacturing.
• The potential health risks associated with the recalled product could impact consumer trust in Endo International plc and Par Pharmaceutical, Inc.
• The recall of a significant lot of Treprostinil Injection may lead to financial implications for the company due to potential losses in sales and reputation damage.
• The need for a recall highlights the importance of stringent quality assurance processes to prevent such incidents in the future.

DUBLIN, March 12, 2024 /PRNewswire/ -- 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. 

The image included with this release shows the vial label of the affected lot.

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 ET.  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: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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.

About Endo
Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at www.endo.com or connect with us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements
Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation, including, but not limited to, statements with respect to the voluntary recall of one lot of Treprostinil Injection, the reasons for and the risks associated with the recall, adverse event reporting, communications with and responses from regulators, and any other statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "outlook," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of risk factors. Additional information concerning risk factors can be found in press releases issued by the Company, as well as public periodic filings with the U.S. Securities and Exchange Commission (the "SEC") and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K.

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SOURCE Endo International plc

FAQ

What is the reason behind the recall of Treprostinil Injection by Endo International plc?

The recall is due to the potential presence of silicone particulates in the product solution, posing health risks to consumers.

Which lot of Treprostinil Injection is affected by the recall?

Lot 57014, with an expiration date of 04/2024, is the only lot affected by this recall.

What are the risks associated with using the recalled product?

The risks include local irritation, swelling, and potential blockage of blood vessels in vital organs, leading to severe health issues like stroke or death.

How can consumers report adverse reactions or quality problems related to the recalled product?

Consumers can report adverse events to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax.

What actions should wholesalers and hospitals take regarding the recalled product?

Wholesalers and hospitals should immediately discontinue use, stop distribution, and return all existing inventory of Lot 57014 through Inmar, Inc.