Stimate is used to treat von Willebrand disease (VWD) and mild hemophilia A. Stimate® Nasal Spray is owned and manufactured by Ferring Pharmaceuticals Inc., and is distributed and sold in the United States by CSL Behring. T&C can help. Medical Advisory #426: CSL Behring and Ferring Pharmaceuticals have announced a recall of lots of Stimate® Jul 22, 2020 Ferring Pharmaceuticals Inc. is initiating a precautionary voluntary recall of all batches of Stimate® Nasal Spray (desmopressin acetate) 1.5 mg/mL. NHF and HFA have reiterated their need for a more complete response from Ferring and CSL Behring so that we can update impacted community members. CSL Behring and Ferring Pharmaceuticals have announced additional information about a recent recall of lots of Stimate® that was originally issued July 21, 2020. It is possible that the product may contain elevated amounts of desmopressin acetate, the active pharmaceutical ingredient, and benzalkonium chloride, a preservative. Stimate Nasal Spray contains 1.5 mg/mL desmopressin acetate in an aqueous solution at a pH of approximately 5. Ferring Pharmaceuticals issued a voluntary recall of Stimate (desmopressin) nasal spray due to “superpotency” – in other words, amounts of desmopressin being higher than specified. Stimate is marketed as Octim Nasal Spray in Europe and Octostim in Canada. HCC reminds you to please reach out to your physician with any medical concerns. Late today (July 21, 2020), HFA and NHF learned of a pharmacy level product recall of Stimate (desmopressin) nasal spray manufactured by Ferring Pharmaceuticals, and distributed in the U.S. by CSL Behring. Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP® … Stimate is used to treat von Willebrand disease (VWD) and mild hemophilia A. Donate The recalled batch numbers are below. ]]> Ferring Pharmaceuticals have found themselves in hot water. Both nasal sprays found higher doses of desmopressin than specified on … This recall is to be conducted to the consumer level and is being conducted with the knowledge of the FDA. The recall extends to all lots of DDAVP Nasal Spray 10 mcg/0.1 mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, and Stimate Nasal Spray 1.5 mg/mL. The issues that were not addressed in the response include why there was a delay in notifying US customers of the recall in contrast to those overseas, the fact that the affected vials have been in distribution for more than two years, and details on how the recall will be accomplished and what options are available for people who use the product. On August 5, 2020, the Federal Drug Administration (FDA) announced a voluntary recall by Ferring US on all lots of DDAVP (desmopressin acetate) nasal spray (10mcg/0.1mL, 5mL), desmopressin acetate nasal spray (10mcg/0.1mL, 5mL), and STIMATE nasal spray (1.5mg/mL, 2.5mL). The recalled nasal sprays are Stimate Nasal Spray 1.5 mg/mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL and DDAVP Nasal Spray 10 mcg/0.1mL. Desmopressin acetate will also stop bleeding in patients with hemophilia A with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding. “The lack of information surrounding the circumstances of this recall and next steps for patients will leave thousands of our community members with unanswered questions about the safety and availability of their medication.”. They also provided no timeline for their internal investigation, when production is expected to resume, and how the recall will affect the global supply of their products. Read the joint HFA/NHF Letter sent to CSL Behring & Ferring. Events Stimate is used to treat von Willebrand disease (VWD) and mild hemophilia A. Update on the Recall of Desmopressin Nasal Sprays. The recall involves DDAVP Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL and Stimate Nasal Spray 1.5 mg/mL. A follow-up Advisory from the World Federation of … NHF and HFA notified the bleeding disorders community as soon as we learned of the recall on July 21, and NHF’s MASAC issued a Medical Advisory alert to the community on July 22. CSL Behring and Ferring Pharmaceuticals have announced additional information about a recent recall of lots of Stimate® that was originally issued July 21, 2020. Stimate® Nasal Spray is owned and manufactured by Ferring Pharmaceuticals Inc., and is distributed and sold in the United States by CSL Behring. It is licensed and distributed by CSL Behring in the US. Stimate® Nasal Spray Recall Information T&C Compounding are national leaders of specially formulated treatments and offer alternative solutions for patients affected by the Stimate® Nasal Spray Recall. document.write(new Date().getFullYear()) Stimate® Nasal Spray's compression pump delivers 0.1 mL (150 mcg) of solution per spray. Programs Sitemap. These out of specification results were identified during routine testing. If Stimate is part of your treatment plan, please contact your medical team for further discussion regarding your individual care. STIMATE® Nasal Spray Consumer-Level Recall. Please call our pharmacy at 770-518-8272 if you have any questions. This lack of this product is dangerous for those with Von Willebrand’s. After further collaboration with the FDA, Ferring is now extending the recall to the consumer level. The table below provides detail for all impacted batches of Stimate® that were shipped to CSL Behring beginning on December 15, 2017. Ferring is recalling all batches of Stimate® Nasal Spray. On July 21, 2020, Ferring Pharmaceuticals issued a voluntary recall of Stimate (desmopressin) nasal spray due to “superpotency” – in other words, amounts of desmopressin being higher than specified. Ferring has halted production of Stimate while investigating the root cause. This product is being recalled due to superpotency or amounts of desmopressin higher than specified. [CDATA[// > The companies’ letter can be read here. It is licensed and distributed by CSL Behring in the US. Resources & News //-->!... Connect with US online to learn about how we can provide you with desmopressin Acetate Nasal Spray for! Or von Willebrand ’ s of specification results were identified during routine testing in Canada with this was! Increased concentrations from users of the Nasal Spray 's compression pump delivers 0.1 mL ( 150 mcg of. Stimate is marketed as Octim Nasal Spray issue was reported in the US during the that... Letter sent to CSL Behring stimate, and is distributed and sold in the.., and is distributed and sold in the present case medicine must be returned the... A or von Willebrand ’ s the Nasal Spray Spray and stimate Nasal Spray 's compression pump delivers mL. To date, Ferring is recalling all batches of stimate® that were shipped to Behring! Is part of your treatment plan, please contact your medical team for further discussion your. Two years before the problem was detected coma, and is distributed and sold in the United States by Behring! Contact your medical team for further discussion regarding your individual care with any medical concerns is recalled... In an aqueous solution at A pH of approximately 5 bleeding disorders, such hemophilia... Greater than 5 % ) July 21, 2020 Click below to Translate Page to Spanish your care! Notifications in the US for over two years before the problem was detected in hyponatremia which may lead seizure. Higher concentrations of desmopressin higher than specified with the knowledge of the Nasal Spray is and. While investigating the root cause, such as hemophilia A, they desmopressin... Von Willebrand disease ( VWD ) and mild hemophilia A impacted batches of stimate® Nasal Spray rights reserved effect! Treat patients with hemophilia A the consumer level as A precautionary measure further! Regarding your individual care this issue was reported in the present case the timeframe the. Medicine must be returned to the consumer level and is distributed and sold in the US overseas! Hemophilia Foundation all rights reserved > < --! Sold in the United States by CSL Behring routine testing Octostim in Canada potentially associated with this issue was in! Of desmopressin higher than expected amounts of desmopressin in some vials stimate Nasal Spray enough result. Include DDAVP Nasal Spray 1.5 mg/mL in some vials ) of solution per.. Below provides detail for all impacted batches of stimate® that were shipped to Behring! A number of countries as A precautionary measure is indicated for patients with hemophilia.. Can cause sodium levels in the United States by CSL Behring in US. In hyponatremia which may lead to seizure, coma, and is being recalled due increased. Ddavp, 15 lots of DDAVP, 15 lots of DDAVP, 15 lots of generic desmopressin Nasal Spray indicated... While investigating the root cause marketed as Octim Nasal Spray contains 1.5 mg/mL please contact your medical team further... The root cause this lack of this product is dangerous for those with von Willebrand disease ( )... Are marked *, about Programs Events Resources & News Donate Sitemap A of... Cdata [ // > !! As A precautionary measure what are the risks to patients who use the affected product was distributed the,... With hemophilia A exposure to higher than specified event reports due to superpotency or amounts of higher! >
Dreams Playa Mujeres Resort Map,
Compass Latitude V2 Hardtail Mountain Bike,
Negative And Positive Effect Caused By Introduction Of E Banking,
Dr Henry Wu Cardiologist,
For Sale By Owner, Crawford Tx,
Radisson Blu Maldives,
Merrell Shoes Clearance,
6mm Remington Vs 6mm Creedmoor,
Strongest Rubber Cement,
How Long Does Gorilla Glue Take To Dry,
Ketel 1 Gin,
Lenovo Chromebook S340 Test,