The corporate is recalling one lot of the product due to the potential presence of silicone particulates.
Endo Worldwide introduced on March 12, 2024 that certainly one of its working corporations, Par Pharmaceutical, is voluntarily recalling one lot of Treprostinil Injection 20 mg/20 mL (1 mg/mL) due to the potential presence of silicone particulates within the particle resolution (1).
Treprostinil Injection is a prostacyclin vasodilator used to treatpulmonary arterial hypertension. It’s formulated for subcutaneous or intravenous infusion. In line with the corporate, administration of an injectable product containing particulate matter could trigger irritation or swelling. Extra severely, if the particulates attain the blood vessels, they will journey to organs and block blood vessels, which may trigger a stroke or dying.
The recalled product was distributed in 20-mL multidose vials as sterile options in water for injection. Vials are individually packaged in cartons below NDC #42023-206-01. The impacted lot, 57014, was distributed nationwide to wholesalers and hospitals from June 16, 2022 by Oct. 17, 2022 and has an expiration date of 04/2024.
Written notification concerning the recall has been despatched to wholesale accounts and hospitals that acquired the affected lot. The corporate said in a press launch that, “Wholesale distributors and hospital pharmacies which have the product being recalled ought to instantly discontinue use and cease distribution instantly. If in case you have additional distributed the recalled product, please notify your accounts or any extra places which can have acquired the recalled product.”
The corporate states that it has not acquired any experiences of adversarial occasions associated to the recall as of the date of the press launch. Hostile reactions could also be reported to FDA by way of it’s MedWatch Hostile Occasion Reporting program.
There are regulatory tips in place to mitigate the issue of particulates. In line with the FDA steerage doc, Inspection of Injectable Products for Visible Particulates, affected person security will be impacted by seen particles in injectable merchandise (2). The steerage states that corporations ought to develop and implement a “holistic, risk-based strategy” to controlling these particulates and stopping contamination. The steerage doc states, “The medical manifestations of adversarial occasions brought on by particulate contamination range and will depend upon the route of administration (e.g., intravascular, intravisceral, intramuscular), affected person inhabitants, and nature or class of the particulates themselves (e.g., bodily measurement or form, amount, chemical reactivity to sure cells or tissues, immunogenicity, infectivity, carcinogenicity). Particulates in intravascular or intravisceral injections usually may cause extra adversarial occasions than these in subcutaneous or intramuscular injections.”
Threat assessments ought to be performed throughout product improvement, in accordance with the FDA steerage doc, and any seen particulates which will pose a danger ought to be recognized. “Producers must also think about the potential sources of particulates, applicable analytical strategies to observe them, and mitigation methods to forestall their presence within the last product,” the steerage doc states.
Visible inspection of the product ought to be a part of a program to make sure merchandise are freed from contaminates, in accordance with the company. “Throughout injectable product improvement, producers ought to set up procedures for inspecting the product, statistical sampling plan(s), acceptance/rejection standards, and procedures for evaluating inspection outcomes. Inspection procedures carried over from one other web site or one other product could not at all times be appropriate for a brand new product,” the company states within the steerage doc.
References
- FDA. Par Pharmaceutical Points Voluntary Nationwide Recall of One Lot of Treprostinil Injection Because of Potential for Silicone Particulates within the Product Answer. Press Launch. March 12, 2024.
- FDA. Draft Guidance for Industry,Inspection of Injectable Products for Visible Particulates. (CDER, CBER, CVM, December 2021.