FOR IMMEDIATE RELEASE – Parsippany, NJ – August 5, 2020– Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP® Nasal … DDAVP Nasal Spray should only be used in patients where orally administered formulations are not feasible. 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. DDAVP is a potent antidiuretic which, when administered, may lead to water intoxication and/or … 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. Ferring initiated the worldwide recall over the summer, citing higher-than-specified concentrations of desmopressin — a synthetic analogue of vasopressin — in several formulations. The voluntary recall … These out of specification results were … One non-fatal event potentially associated with this issue occurred in the U.S., within the timeframe that the recalled lots were distributed. 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. 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. 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. We are sorry that this post was not useful for you! 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. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Tagged desmopressin, Ferring Pharmaceuticals, intranasal desmopressin, product recall, Stimate nasal spray. Stimate Nasal Spray boosts levels of blood clotting factor VIII and von Willebrand factor. 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 … It does not provide medical advice, diagnosis or treatment. However, patients may want to consult their providers and consider returning any unused product to pharmacies, according to the World Federation of Hemophilia. This product has a … He currently lives in Long Beach, California. 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. 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. About this Recall: Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP nasal spray 10 mcg/0.1mL, 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. Stimate is marketed as Octim Nasal Spray in Europe and Octostim in Canada. 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. 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 . 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. Click here to subscribe to the Hemophilia News Today Newsletter! Bausch Health has desmopressin nasal spray on back order and the company estimates a release date of mid-February 2021. Recalls on DDAVP, Desmopressin, and Stimate Nasal Sprays. 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. Nasal Spray 10 mcg/0.1 mL, and Stimate® Nasal Spray 1.5 mg/mL . 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. Manufacturing will resume after an investigation into the recall is complete and any necessary corrective measures are taken. 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 … 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… 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. … 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. 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. Forest Ray received his PhD in systems biology from Columbia University, where he developed tools to match drug side effects to other diseases. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. Recalled product label U.S. Food and Drug Administration Ferring has DDAVP nasal spray on back order and the company cannot estimate a release date. 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). A complete list of affected lots is included in the recall announcement made by the U.S. Food and Drug Administration. DDAVP Nasal Spray and Desmopressin Acetate Nasal Spray are used for this indication, and in managing head trauma or surgery in the pituitary region. Exposure to higher than expected amounts of desmopressin may result in hyponatremia which may lead to seizure, coma, and death. 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. DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL. Subcategory: Drugs. Update on the Recall of Desmopressin Nasal Sprays. 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. The Board of Pharmacy has received notice of the following product recall. Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with DDAVP (desmopressin acetate). Hemophilia News Today is strictly a news and information website about the disease. Drug Recall . CSL Behring has Stimate nasal spray on back order and the company estimates the product will not be available until 2022. 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 is marketed as Octim Nasal Spray in Europe and Octostim in Canada. He has since worked as a journalist and science writer, covering topics from rare diseases to the intersection between environmental science and social justice. 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. Be the first to rate this post. No votes so far! 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. Most countries only require retailers to return the affected lots. 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. recall information. The Board strongly encourages pharmacies to immediately review their quality assurance and recall policies and procedures to determine if any corrective action is required. On August 5, 2020, Ferring Pharmaceuticals announced a recall of three nasal sprays due to superpotency of the ingredients. As of mid-July 2020, affected batches of these products have been recalled in a number of countries as a precautionary measure. 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. 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®. Posts about DDAVP Nasal Spray written by NationalAddictionNews. 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. Recall Of DDAVP® Nasal Spray 10mcg/0.1ml, Desmopressin Acetate Nasal Spray 10mcg/0.1ml, STIMATE® Nasal Spray 1.5mg/ml Due To Superpotency . The manufacturer has no known reports of adverse events associated with the superpotent product during the affected timeframe. 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 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 … 3. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. 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. REASON FOR R ECALL:. Desmospray® 0.1 mg/ml Nasal Spray PL 03194/0024 RECALLING F IRM: Ferring Pharmaceuticals US . 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. Type of communication: Drug Recall. 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. Manufacturing will resume after an investigation into the recall is complete and any necessary corrective measures are taken. Product Description: Product Description. Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with DDAVP (desmopressin acetate). Starting date: July 14, 2020. 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.” 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. Stimate is marketed as Octim Nasal Spray in Europe and Octostim in Canada. Product: DDAVP® Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL NDC 55566-2500-0 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, 2.5 mL/5 mL (2020-07-14) Report a Concern. 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. 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. … Ferring Pharmaceuticals US. 1 Vial of DDAVP® Nasal Spray, 10 mcg /0.1 mL, 5 mL Bottle (50 Doses) DDAVP® Nasal Spray Packaged Lot # Vial EXP Date . More on the FDA website . Recall Reason Description. DATE OF RECALL: August 05, 2020. 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%. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. Manufacturing will resume after an investigation into the recall is complete and any necessary corrective measures are taken. Carton EXP Date . This recall is due to superpotency, or amounts of desmopressin … Copyright © 2013-2021 All rights reserved. Too much desmopressin can cause sodium levels in the blood to drop enough to result in seizures, coma, and death. DDAVP Nasal Spray should only be used in patients where orally administered formulations are not feasible. 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. Hazard classification: Superpotency. Ferring Pharmaceuticals US is recalling the following desmopressin nasal spray products for possible superpotency identified during routine product testing. The company and other agencies around the world made recall announcements from July 10 to Aug. 5. Recalls 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. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. DRUG NAME: DDAVP 10mcg/0.1ml , Desmopressi n Acetate 10mcg/0.1ml and Stimate 1.5mg/ml Nasal Sprays. 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. Company Name: Ferring Pharmaceuticals US Brand Name: Brand Name(s) Ferring, Amring, CSL Behring . 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. Ferring Pharmaceuticals US is recalling the following desmopressin nasal spray products for possible superpotency identified during routine product testing. 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 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. Exposure to higher than expected amounts of desmopressin may result in hyponatremia which may lead to seizure, coma, and death. DDAVP Nasal Spray, 2.5 mL/5 mL (2020-07-14) Report a Concern. 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). Ferring has not reported seeing an increase in adverse events due to the increased desmopressin levels. This recall was issued due to superpotency or amounts of desmopressin higher than specified. September 17, 2020. Not reported seeing an increase in adverse events due to superpotency he developed tools to match Drug side to. Is strictly a News and information website about the disease product during the affected lots higher than specified products being. 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