Starting date: July 14, 2020. The manufacturer has no known reports of adverse events associated with the superpotent product during the affected timeframe. Ferring Pharmaceuticals US is recalling the following desmopressin nasal spray products for possible superpotency identified during routine product testing. The European Haemophilia Consortium (EHC) would like to provide an update on its November 2020 statement on the international recall of all Ferring Pharmaceutical Limited nasal sprays containing desmopressin, including Octim®, Octostim®, Desmospray®, DDAVP Spray® and Stimate®. 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. It does not provide medical advice, diagnosis or treatment. DDAVP is a potent antidiuretic which, when administered, may lead to water intoxication and/or … This recall was issued due to superpotency or amounts of desmopressin higher than specified. 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. September 17, 2020. Minirin ® is also sold as Desmospray ® in Europe, DDAVP ® Spray in Canada, DDAVP ® Nasal Spray in the United States, and under other brand names in other parts of the world. On August 5, 2020, Ferring Pharmaceuticals announced a recall of three nasal sprays due to superpotency of the ingredients. Ferring … Manufacturing will resume after an investigation into the recall is complete and any necessary corrective measures are taken. 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. August 05, 2020 -- 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 listed in the table below to the consumer level. 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. No votes so far! However, patients may want to consult their providers and consider returning any unused product to pharmacies, according to the World Federation of Hemophilia. recall information. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. We are sorry that this post was not useful for you! 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%. 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). Too much desmopressin can cause sodium levels in the blood to drop enough to result in seizures, coma, and death. This recall is due to superpotency, or amounts of desmopressin … 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. Product: DDAVP® Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL NDC 55566-2500-0 Ferring has not reported seeing an increase in adverse events due to the increased desmopressin levels. 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. Ferring Pharmaceuticals US is recalling the following desmopressin nasal spray products for possible superpotency identified during routine product testing. 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. Stimate is marketed as Octim Nasal Spray in Europe and Octostim in Canada. Tagged desmopressin, Ferring Pharmaceuticals, intranasal desmopressin, product recall, Stimate nasal spray. 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. A recall on Ferring Pharmaceuticals‘ intranasal desmopressin compounds — used to treat mild to moderate hemophilia A and von Willebrand disease type 1 — is expected to affect the availability of these products until at least mid- to late-2021, according to an advisory from the World Federation of Hemophilia. CSL Behring has Stimate nasal spray on back order and the company estimates the product will not be available until 2022. Company Name: Ferring Pharmaceuticals US Brand Name: Brand Name(s) Ferring, Amring, CSL Behring . DDAVP Nasal Spray, 2.5 mL/5 mL (2020-07-14) Report a Concern. Copyright © 2013-2021 All rights reserved. The WFH has learned of a voluntary product recall of desmopressin nasal spray by Ferring Pharmaceuticals, due to out of specification results of the active ingredient. 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. Click here to subscribe to the Hemophilia News Today Newsletter! Manufacturing will resume after an investigation into the recall is complete and any necessary corrective measures are taken. DRUG NAME: DDAVP 10mcg/0.1ml , Desmopressi n Acetate 10mcg/0.1ml and Stimate 1.5mg/ml Nasal Sprays. DATE OF RECALL: August 05, 2020. The Board of Pharmacy has received notice of the following product recall. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. Superpotency. Recalls Drug Recall . Desmospray® 0.1 mg/ml Nasal Spray PL 03194/0024 … 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. 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. … FOR IMMEDIATE RELEASE – Parsippany, NJ – August 5, 2020– 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 listed in the table below to the consumer level. Exposure to higher than expected amounts of desmopressin may result in hyponatremia which may lead to seizure, coma, and death. DDAVP Nasal Spray should only be used in patients where orally administered formulations are not feasible. 3. DDAVP Nasal Spray should only be used in patients where orally administered formulations are not feasible. 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. 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. Ferring initiated the worldwide recall over the summer, citing higher-than-specified concentrations of desmopressin — a synthetic analogue of vasopressin — in several formulations. 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 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. Product Description: Product Description. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. Recall Of DDAVP® Nasal Spray 10mcg/0.1ml, Desmopressin Acetate Nasal Spray 10mcg/0.1ml, STIMATE® Nasal Spray 1.5mg/ml Due To Superpotency . Stimate Nasal Spray boosts levels of blood clotting factor VIII and von Willebrand factor. More on the FDA website . Carton EXP Date . Type of communication: Drug Recall. 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.” REASON FOR R ECALL:. Subcategory: Drugs. August 05, 2020 -- 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 listed in the table below to the consumer level. One non-fatal event potentially associated with this issue occurred in the U.S., within the timeframe that the recalled lots were distributed. 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. 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 Company Announcement. 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 . Hemophilia News Today is strictly a news and information website about the disease. 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). DDAVP Nasal Spray and Desmopressin Acetate Nasal Spray are used for this indication, and in managing head trauma or surgery in the pituitary region. The company and other agencies around the world made recall announcements from July 10 to Aug. 5. Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with DDAVP (desmopressin acetate). Update on the Recall of Desmopressin Nasal Sprays. 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. Stimate is marketed as Octim Nasal Spray in Europe and Octostim in Canada. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. DDAVP Nasal Spray, 2.5 mL/5 mL (2020-07-14) Report a Concern. Nasal Spray 10 mcg/0.1 mL, and Stimate® Nasal Spray 1.5 mg/mL . Ferring Pharmaceuticals US. 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. Be the first to rate this post. 1 Vial of DDAVP® Nasal Spray, 10 mcg /0.1 mL, 5 mL Bottle (50 Doses) DDAVP® Nasal Spray Packaged Lot # Vial EXP Date . 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. Class 2 Medicines Recall: Ferring Pharmaceuticals Limited, desmopressin nasal spray (all strengths), PL 03194/0024, PL 03194/0090, PL 03194/0056, EL (20)A/29 - GOV.UK. Ferring has DDAVP nasal spray on back order and the company cannot estimate a release date. Exposure to higher than expected amounts of desmopressin may result in hyponatremia which may lead to seizure, coma, and death. RECALLING F IRM: Ferring Pharmaceuticals US . 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. About this Recall: Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP nasal spray 10 mcg/0.1mL, 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 … FOR IMMEDIATE RELEASE – Parsippany, NJ – August 5, 2020– Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP® Nasal … Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with DDAVP (desmopressin acetate). Forest Ray received his PhD in systems biology from Columbia University, where he developed tools to match drug side effects to other diseases. A complete list of affected lots is included in the recall announcement made by the U.S. Food and Drug Administration. August 05, 2020 -- 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 listed in the table below to the consumer level. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. On August 26, 2020, the U.S. Food and Drug Administration (FDA) announced that 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 listed at the website below as a Class I Recall. Desmopressin nasal spray out of stock due to recall 22 Jul 2020 All the existing supplies of the following preparations of desmopressin nasal spray are being recalled by Ferring, so they are currently out of stock. These out of specification results were … 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.” The recall includes 6 lots of DDAVP… He currently lives in Long Beach, California. The Board strongly encourages pharmacies to immediately review their quality assurance and recall policies and procedures to determine if any corrective action is required. 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. The recall involves 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. Bausch Health has desmopressin nasal spray on back order and the company estimates a release date of mid-February 2021. N14695F 08 2020 08 2020 N15627C 10 2020 10 2020 P11319P 01 2021 01 2021 P11706F 04 2021 04 2021 R11842C 03 2022 03 2022 R13637E 06 2022 06 2022 Ferring Pharmaceuticals Inc. is initiating a recall of all batches of DDAVP® Nasal … DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL. The voluntary recall … Recalls on DDAVP, Desmopressin, and Stimate Nasal Sprays. Stimate is marketed as Octim Nasal Spray in Europe and Octostim in Canada. Most countries only require retailers to return the affected lots. This product has a … Manufacturing will resume after an investigation into the recall is complete and any necessary corrective measures are taken. 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. Canada/Ottawa: Ferring Pharmaceuticals Inc., a Toronto, Ontario establishment, recalls certain batch/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), a consequential risk of drug overdose, a serious health hazard. 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. 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 Recalled product label U.S. Food and Drug Administration 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. 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. Hazard classification: Posts about DDAVP Nasal Spray written by NationalAddictionNews. 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 … 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. Recall Reason Description. 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. Announcement made by the U.S. Food and Drug Administration 2.5 mL/5 mL ( ). To higher than specified world-wide postmarketing experience in patients where orally administered formulations ddavp nasal spray recall not feasible cause... 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