Recall Of DDAVP® Nasal Spray 10mcg/0.1ml, Desmopressin Acetate Nasal Spray 10mcg/0.1ml, STIMATE® Nasal Spray 1.5mg/ml Due To Superpotency . Recall of DDAVP Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE Nasal Spray 1.5 mg/mL by Ferring Pharmaceuticals US due to superpotency. RECALLING F IRM: Ferring Pharmaceuticals US . Update: Health Canada has also announced a recall of three lots of Ferring’s DDAVP desmopressin nasal spray “because the product may contain a higher than labelled dose of the active ingredient (desmopressin) and could pose an overdose risk.” A number of other countries have issued recall alerts for Minirin desmopressin nasal spray. The Board strongly encourages pharmacies to immediately review their quality assurance and recall policies and procedures to determine if any corrective action is required. The manufacturer has no known reports of adverse events associated with the superpotent product during the affected timeframe. Company Name: Ferring Pharmaceuticals US Brand Name: Brand Name(s) Ferring, Amring, CSL Behring . The Board of Pharmacy has received notice of the following product recall. Recalled product label U.S. Food and Drug Administration Stimate is marketed as Octim Nasal Spray in Europe and Octostim in Canada. Starting date: July 14, 2020 Type of communication: Drug Recall Subcategory: Drugs Hazard classification: Type II Source of recall: Health Canada Issue: Product Safety Audience: General Public, Healthcare Professionals, Hospitals Manufacturing will resume after an investigation into the recall is complete and any necessary corrective measures are taken. Most countries only require retailers to return the affected lots. Three weeks after recalling numerous lots of desmopressin nasal sprays in the UK and a number of other countries, Ferring has issued a recall of all lots of DDAVP 10 mcg/0.1ml, Stimate 1.5 mg/ml, and generic desmopressin 10 mcg/0.1ml nasal sprays in the US “due to superpotency or amounts of desmopressin higher than specified.” Ferring US Issues Voluntary Nationwide Recall of DDAVP Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE Nasal Spray 1.5 mg/mL Due to Superpotency. Company Announcement. … As of mid-July 2020, affected batches of these products have been recalled in a number of countries as a precautionary measure. He has since worked as a journalist and science writer, covering topics from rare diseases to the intersection between environmental science and social justice. Update on the Recall of Desmopressin Nasal Sprays. DDAVP Nasal Spray should only be used in patients where orally administered formulations are not feasible. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Ferring Pharmaceuticals US is recalling the following desmopressin nasal spray products for possible superpotency identified during routine product testing. Be the first to rate this post. Ferring’s recall includes all batches of Minirin ® desmopressin nasal spray (0.1 mg/ml), which is indicated as antidiuretic therapy in the management of central diabetes insipidus. Ferring has DDAVP nasal spray on back order and the company cannot estimate a release date. September 17, 2020. Desmospray® 0.1 mg/ml Nasal Spray PL 03194/0024 Stimate is marketed as Octim Nasal Spray in Europe and Octostim in Canada. 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. Stimate Nasal Spray boosts levels of blood clotting factor VIII and von Willebrand factor. Exposure to higher than expected amounts of desmopressin may result in hyponatremia which may lead to seizure, coma, and death. DATE OF RECALL: August 05, 2020. Carton EXP Date . Type of communication: Drug Recall. The company and other agencies around the world made recall announcements from July 10 to Aug. 5. The recalled nasal sprays are found under the following names: DDAVP® Nasal Spray 10 mcg/0.1mL; Desmopressin Acetate Nasal Spray 10 mcg/0.1mL; STIMATE® Nasal Spray 1.5 mg/mL; The manufacturer said it had not noted an increase in adverse event reports tied to higher-than-normal levels of desmopressin. Product: DDAVP® Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL NDC 55566-2500-0 Desmospray® 0.1 mg/ml Nasal Spray PL 03194/0024; Desmopressin 0.1 mg/ml Nasal Spray PL 03194/0090; Octim® 1.5mg/ml Nasal Spray solution PL 03194/0056 DDAVP Nasal Spray, 2.5 mL/5 mL (2020-07-14) Report a Concern. Ferring Inc. is recalling three lots of DDAVP Spray (desmopressin acetate nasal solution, 10 micrograms/spray) because the product may contain a higher than labelled dose of the active ingredient (desmopressin) and could pose an overdose risk. This recall was issued due to superpotency or amounts of desmopressin higher than specified. Please note that all the existing supplies of the following preparations of desmopressin nasal spray are being recalled by Ferring so they are currently out of stock. Pharma News: Ferring Pharmaceuticals is initiating a precautionary recall of all MINIRIN Nasal Spray (desmopressin acetate) batches following the detection of a low volume and out-of-specification results in desmopressin content in some vials.. MINIRIN Nasal Spray (desmopressin acetate) is indicated for diabetes insipidus, nocturnal enuresis and renal … DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL. More on the FDA website . recall information. During the interruption, therapeutic alternatives include clotting factor concentrates, Cyklokapron (tranexamic acid), and other forms of desmopressin, such as subcutaneous (under-the-skin) or intravenous (into-the-vein) injections. Tagged desmopressin, Ferring Pharmaceuticals, intranasal desmopressin, product recall, Stimate nasal spray. Fresh Look at Mechanism Finds ‘Important Role’ in Factor VIII Regulation, ‘In the Twinkling of an Eye’: The Moments That Change Our Lives, Roctavian, Hem A Gene Therapy, Sustains Drop in Bleeding Rates, Phase 3 Data Show, How to Help Your Doctor Take Hemophilia Seriously. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. However, patients may want to consult their providers and consider returning any unused product to pharmacies, according to the World Federation of Hemophilia. According to the agency, the risks associated with higher than specified amounts of desmopressin relate to abnormally low levels of sodium in the blood, i.e., hyponatremia, which could eventually lead to … DDAVP is a potent antidiuretic which, when administered, may lead to water intoxication and/or … We are sorry that this post was not useful for you! These out of specification results were … CSL Behring has Stimate nasal spray on back order and the company estimates the product will not be available until 2022. Stimate is marketed as Octim Nasal Spray in Europe and Octostim in Canada. Patients and caregivers may need training on how to administer injections and should coordinate care with their healthcare providers, particularly in how to manage severe bleeding events and surgery-related care. About this Recall: Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP nasal spray 10 mcg/0.1mL, Ferring has not reported seeing an increase in adverse events due to the increased desmopressin levels. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. … DRUG NAME: DDAVP 10mcg/0.1ml , Desmopressi n Acetate 10mcg/0.1ml and Stimate 1.5mg/ml Nasal Sprays. In addition to blood-clotting disorders, desmopressin works as an anti-diuretic — to decrease urination — and is used to treat central diabetes insipidus, wherein the body doesn’t make the hormone vasopressin. Ferring has announced a recall of 3 products: DDAVP® Nasal Spray 10mcg/0.1mL, Desmopressin Acetate Nasal Spray 10mcg/0.1mL, and Stimate® Nasal Spray 1.5mg/mL. 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). FOR IMMEDIATE RELEASE – Parsippany, NJ – August 5, 2020– Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP® Nasal … Bausch Health has desmopressin nasal spray on back order and the company estimates a release date of mid-February 2021. Ferring Pharmaceuticals US. DDAVP Nasal Spray should only be used in patients where orally administered formulations are not feasible. Desmopressin is a synthetic analog of the antidiuretic hormone arginine vasopressin and works by increasing adenosine monophosphate (cAMP) in renal tubular cells, increasing water permeability, and decreasing urine volume and increasing urine osmolarity. Additionally, desmopressin increases plasma levels of von Willebrand factor, Factor VIII, and t-PA. Desmopressin nasal products are indicated for use in a variety of conditions such as an antidiuretic therapy in the management of central cranial diabetes insipidus, temporary polyuria and polydipsia following head trauma, pituitary surgery, hemophilia A with Factor VIII coagulant activity levels greater than 5%, or mild to moderate classic von Willebrand disease (Type 1) with Factor VIII activity levels greater than 5%. 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 listed in the table are recalled. Ferring Pharmaceuticals has posted a market recall 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 . Too much desmopressin can cause sodium levels in the blood to drop enough to result in seizures, coma, and death. REASON FOR R ECALL:. Recall Reason Description. The voluntary recall … Patients and healthcare providers can report any adverse reaction related to superpotent desmopressin nasal products to the FDA’s MedWatch program in 1 of 2 ways. Click here to subscribe to the Hemophilia News Today Newsletter! 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. DDAVP Nasal Spray, 2.5 mL/5 mL (2020-07-14) Report a Concern. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. Manufacturing will resume after an investigation into the recall is complete and any necessary corrective measures are taken. Posts about DDAVP Nasal Spray written by NationalAddictionNews. No votes so far! Ferring US Issues Voluntary Nationwide Recall of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL Due to Superpotency. 3. Starting date: July 14, 2020. Hazard classification: About this Recall: Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP nasal spray 10 mcg/0.1mL, desmopressin acetate nasal spray 10 mcg/0.1mL, and Stimate® nasal spray 1.5 mg/mL. 1 Vial of DDAVP® Nasal Spray, 10 mcg /0.1 mL, 5 mL Bottle (50 Doses) DDAVP® Nasal Spray Packaged Lot # Vial EXP Date . Additional information is available at the following links: 50 N Medical Dr A050Salt Lake City, Utah 84132, Complete a paper form and fax to 1-800-FDA-0178. A complete list of affected lots is included in the recall announcement made by the U.S. Food and Drug Administration. Copyright © 2013-2021 All rights reserved. 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. 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