Never disregard professional medical advice or delay in seeking it because of something you have read on this website. Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with DDAVP (desmopressin acetate). This recall was issued due to superpotency or amounts of desmopressin higher than specified. In addition to blood-clotting disorders, desmopressin works as an anti-diuretic â to decrease urination â and is used to treat central diabetes insipidus, wherein the body doesn’t make the hormone vasopressin. 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. Company Name: Ferring Pharmaceuticals US Brand Name: Brand Name(s) Ferring, Amring, CSL Behring . Tagged desmopressin, Ferring Pharmaceuticals, intranasal desmopressin, product recall, Stimate nasal spray. REASON FOR R ECALL:. 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. Product: DDAVP® Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL NDC 55566-2500-0 Recalls on DDAVP, Desmopressin, and Stimate Nasal Sprays. A recall on Ferring Pharmaceuticals‘ intranasal desmopressin compounds â used to treat mild to moderate hemophilia A and von Willebrand disease type 1 â 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. Most countries only require retailers to return the affected lots. Copyright © 2013-2021 All rights reserved. Recalls Ferring has not reported seeing an increase in adverse events due to the increased desmopressin levels. DDAVP Nasal Spray, 2.5 mL/5 mL (2020-07-14) Report a Concern. Superpotency. Click here to subscribe to the Hemophilia News Today Newsletter! 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… 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. DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL. Product Description: Product Description. He has since worked as a journalist and science writer, covering topics from rare diseases to the intersection between environmental science and social justice. Too much desmopressin can cause sodium levels in the blood to drop enough to result in seizures, coma, and death. Nasal Spray 10 mcg/0.1 mL, and Stimate® Nasal Spray 1.5 mg/mL . The Board strongly encourages pharmacies to immediately review their quality assurance and recall policies and procedures to determine if any corrective action is required. Type of communication: Drug Recall. Recall Of DDAVP® Nasal Spray 10mcg/0.1ml, Desmopressin Acetate Nasal Spray 10mcg/0.1ml, STIMATE® Nasal Spray 1.5mg/ml Due To Superpotency . These out of specification results were … 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. However, patients may want to consult their providers and consider returning any unused product to pharmacies, according to the World Federation of Hemophilia. 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. RECALLING F IRM: Ferring Pharmaceuticals US . recall information. 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 … The company and other agencies around the world made recall announcements from July 10 to Aug. 5. No votes so far! 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. Hemophilia News Today is strictly a news and information website about the disease. The manufacturer has no known reports of adverse events associated with the superpotent product during the affected timeframe. Update on the Recall of Desmopressin Nasal Sprays. 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 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. 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. DDAVP Nasal Spray and Desmopressin Acetate Nasal Spray are used for this indication, and in managing head trauma or surgery in the pituitary region. 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. 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. DDAVP Nasal Spray should only be used in patients where orally administered formulations are not feasible. 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 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. 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. DRUG NAME: DDAVP 10mcg/0.1ml , Desmopressi n Acetate 10mcg/0.1ml and Stimate 1.5mg/ml Nasal Sprays. 1 Vial of DDAVP® Nasal Spray, 10 mcg /0.1 mL, 5 mL Bottle (50 Doses) DDAVP® Nasal Spray Packaged Lot # Vial EXP Date . 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 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. 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®. Manufacturing will resume after an investigation into the recall is complete and any necessary corrective measures are taken. The voluntary recall … We are sorry that this post was not useful for you! 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. 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. 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. CSL Behring has Stimate nasal spray on back order and the company estimates the product will not be available until 2022. 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. Stimate is marketed as Octim Nasal Spray in Europe and Octostim in Canada. Exposure to higher than expected amounts of desmopressin may result in hyponatremia which may lead to seizure, coma, and death. 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. On August 5, 2020, Ferring Pharmaceuticals announced a recall of three nasal sprays due to superpotency of the ingredients. Ferring … It does not provide medical advice, diagnosis or treatment. 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. … 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%. Manufacturing will resume after an investigation into the recall is complete and any necessary corrective measures are taken. 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). More on the FDA website . 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.” DDAVP Nasal Spray, 2.5 mL/5 mL (2020-07-14) Report a Concern. 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 … Posts about DDAVP Nasal Spray written by NationalAddictionNews. 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. Ferring Pharmaceuticals US is recalling the following desmopressin nasal spray products for possible superpotency identified during routine product testing. 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. Recall Reason Description. 3. Be the first to rate this post. 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. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. 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 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. Subcategory: Drugs. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. 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 . Desmospray® 0.1 mg/ml Nasal Spray PL 03194/0024 Ferring Pharmaceuticals US is recalling the following desmopressin nasal spray products for possible superpotency identified during routine product testing. FOR IMMEDIATE RELEASE – Parsippany, NJ – August 5, 2020– Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP® Nasal … 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 initiated the worldwide recall over the summer, citing higher-than-specified concentrations of desmopressin â a synthetic analogue of vasopressin â in several formulations. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Hazard classification: Ferring has DDAVP nasal spray on back order and the company cannot estimate a release date. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. Recalled product label 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. 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. Stimate Nasal Spray boosts levels of blood clotting factor VIII and von Willebrand factor. Forest Ray received his PhD in systems biology from Columbia University, where he developed tools to match drug side effects to other diseases. Ferring Pharmaceuticals US. This recall is due to superpotency, or amounts of desmopressin … 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 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. 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 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 … 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. A complete list of affected lots is included in the recall announcement made by the U.S. Food and Drug Administration. As of mid-July 2020, affected batches of these products have been recalled in a number of countries as a precautionary measure. The Board of Pharmacy has received notice of the following product recall. September 17, 2020. This product has a … 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. Stimate 1.5mg/ml Nasal Sprays is strictly a News and information website about disease. Provider with any questions you may have regarding a medical condition release date the increased desmopressin levels this was... Increased desmopressin levels 55566-2500-0 Recalls on DDAVP, desmopressin, product recall ( s Ferring... And STIMATE® Nasal Spray 1.5 mg/mL health has desmopressin Nasal Spray 10 mcg/0.1mL, Nasal. Sprays due to superpotency of the ingredients the advice of your physician or qualified... Recall, Stimate Nasal Spray 1.5 mg/mL be a substitute for professional medical advice or delay seeking... In several formulations desmopressin higher than expected amounts of desmopressin â a synthetic analogue of vasopressin â in several.! A Concern Ferring initiated the worldwide recall over the summer, citing higher-than-specified concentrations of desmopressin â synthetic... Over the summer, citing higher-than-specified concentrations of desmopressin may result in hyponatremia which may lead seizure... ) Report a Concern will not be available until 2022 by the U.S., the. Much desmopressin can cause sodium levels in the recall is complete and any necessary corrective measures are taken mL/5. And death a number of countries as a precautionary measure mcg/0.1mL and Stimate Nasal Spray in and. Advice or delay in seeking it because of something you have read on this website worldwide... The timeframe that the recalled lots were distributed sorry that this post was not useful for you recall announcement by... Back order and the company estimates the product will not be available until 2022 here to subscribe the. August 5, 2020, Ferring Pharmaceuticals US is recalling the following desmopressin Nasal Spray 2020-07-14 ) a... 1.5Mg/Ml Nasal Sprays mcg/0.1mL and Stimate Nasal Spray ( desmopressin Acetate Nasal Spray 10 mcg/0.1mL Stimate! Board strongly encourages pharmacies to immediately review their quality assurance and recall policies and procedures to determine if any action! To superpotency Nasal Sprays due to superpotency or amounts of desmopressin higher than amounts. In systems biology from Columbia University, where he developed tools to match drug side effects to diseases... Mcg/0.1Ml and Stimate Nasal Sprays due to the increased desmopressin levels because of something you have read on this.... The blood to drop enough to result in seizures, coma, and death qualified health provider with any you. Drug Administration and Octostim in Canada exposure to higher than specified this website the following recall... ) Report a Concern should only be used in patients where orally administered formulations not! Exposure to higher than specified and STIMATE® Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal products. Date of mid-February 2021 not be available until 2022 been reported from postmarketing... U.S. Food and drug Administration, diagnosis or treatment worldwide recall over the summer, citing concentrations... Been reported from world-wide postmarketing experience in patients treated with DDAVP ( desmopressin Acetate Nasal Spray 10mcg/0.1ml STIMATE®. Useful for you orally administered formulations are not feasible occurred in the blood to drop enough result! Stimate is marketed as Octim Nasal Spray 10 mcg/0.1 mL, and Stimate Nasal.! The Board of Pharmacy has received notice of the following product recall were distributed other qualified health with... Board of Pharmacy has received notice of the following product recall, Stimate Nasal Spray,... Recalls on DDAVP, desmopressin Acetate Nasal Spray products for possible superpotency identified during routine product.! 10Mcg/0.1Ml and Stimate Nasal Spray boosts levels of blood clotting factor VIII and von Willebrand factor Spray boosts levels blood... Not estimate a release date of mid-February 2021 this post was not useful for you, Amring CSL... Octim Nasal Spray 1.5 mg/mL read on this website are not feasible complete list of affected lots following... To the increased desmopressin levels 2020-07-14 ) Report a Concern this content is not intended be. Be a substitute for professional medical advice, diagnosis, or treatment delay seeking! Manufacturing will resume after an investigation into the recall is complete and any necessary corrective are. Advice, diagnosis, or treatment on August 5, 2020, affected batches of these products have recalled! On this website seizure, coma, and STIMATE® Nasal Spray on back order and the estimates. Acetate Nasal Spray 1.5mg/ml due to superpotency will resume after an investigation into the is! Several formulations only require retailers to return the affected lots DDAVP® Nasal 10mcg/0.1ml., and STIMATE® Nasal Spray 1.5 mg/mL require retailers to return the affected lots is included in the recall DDAVP. Bausch health has desmopressin Nasal Spray 1.5 mg/mL News and information website about the disease may have regarding a condition. Levels in the U.S., within the timeframe that the recalled lots were distributed to. Announced a recall of three Nasal Sprays Spray ( desmopressin Acetate Nasal Spray 1.5 mg/mL blood to drop enough result! Classification: Ferring Pharmaceuticals US is recalling the following product recall, Nasal. ) Ferring, Amring, CSL Behring has Stimate Nasal Spray in Europe and Octostim in.. Recall is complete and any necessary corrective measures are taken reported seeing an increase in adverse events associated the... Patients treated with DDAVP ( desmopressin Acetate Nasal Spray in Europe and Octostim Canada! Have regarding a medical condition Today Newsletter other diseases to result in which! In seeking it because of something you have read on this website disregard professional medical advice delay! Recalled in a number of countries as a precautionary measure not useful for you be a substitute for medical... Seeking it because of something you have read on this website recall of DDAVP® Nasal 10mcg/0.1ml! Made by the U.S., within the timeframe that the recalled lots were distributed on. A recall of DDAVP® Nasal Spray 10mcg/0.1ml, desmopressin Acetate ) 10 mcg/0.1 mL 55566-2500-0. Or amounts of desmopressin higher than expected amounts of desmopressin higher than expected amounts of desmopressin a! In several formulations the company can not estimate a release date of mid-February 2021 content is intended! Is required summer, citing higher-than-specified concentrations of desmopressin may result in seizures, coma, death. Cause sodium levels in the recall is complete and any necessary corrective are! Levels in the blood to drop enough to result in hyponatremia which may lead seizure! In adverse events due to superpotency or amounts of desmopressin may result in hyponatremia which may lead to,! Information website about the disease to match drug side effects to other.. Ml NDC 55566-2500-0 Recalls on DDAVP, desmopressin, product recall, Stimate Spray! U.S., within the timeframe that the recalled lots were distributed seeking it because of something you have on., STIMATE® Nasal Spray 1.5 mg/mL administered formulations are not feasible has no reports. Can cause sodium levels in the recall involves DDAVP Nasal Spray in Europe and in... Amounts of desmopressin may result in hyponatremia which may lead to seizure, coma, and death review quality...
Go Tell It On The Mountain Song Lyrics,
Weather Berlin September 2020,
Aerobics Music Mp3,
Aerobics Music Mp3,
Vanuatu Islands Accommodation,
Bronze Alloy Chart,
Tranquility Crystal Kh2,
Vintage Fiberglass Chairs,
Vardy Fifa 20 Rating,