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In August 2020, Ferring recalled DDAVP nasal spray, desmopressin nasal spray, and Stimate nasal spray due to higher desmopressin amounts than specified. In mid-August, the European Haemophilia Consortium (EHC) communicated an international recall of all FerringPharmaceuticals Limited nasal sprays containing desmopressin, including Octim®, Octostim®, Desmospray®, DDAVP Spray® and Stimate®, and reported that this may lead to shortages over the course of 2020. Reason for the Shortage. DDAVP and the generic desmopressin nasal sprays are used “as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the … 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. Batch No. Product: Minirin Nasal Spray 0.1mg/ml (2.5ml) (SIN03760P) Active Ingredient: Desmopressin. All the existing supplies of the following preparations of desmopressin nasal spray are being recalled by Ferring, so they are currently out of stock. 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. News Date 21/07/2020 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. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Ferring Pharmaceuticals US is recalling the following desmopressin nasal spray products for possible superpotency identified during routine product testing. The recall applies to all products made in its Florida plant, including nasal mists, sprays, and gels. Stimate® Nasal Spray is owned and manufactured by Ferring Pharmaceuticals Inc., and is distributed and sold in the United States by CSL Behring. Stimate® Nasal Spray Recall Information. The recall includes 6 lots of DDAVP, 15 lots of Stimate, and 16 lots of generic desmopressin nasal spray. About Ferring Pharmaceuticals 8/11/2020. 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. Additional information is available at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ferring-us-issues-voluntary-nationwide-recall-ddavpr-nasal-spray-10-mcg01ml-desmopressin-acetate#:~:text=Ferring%20Pharmaceuticals%20US%20is%20voluntarily,below%20to%20the%20consumer%20level. Major Twice-A-Day 12 Hour Nasal Spray. After further collaboration with the FDA, Ferring is now … ; In Target Stores: Visit the iPads at Guest Services or the iPads at in-aisle Help Centers in select stores. August 4, 2020 In mid-July, Ferring Pharmaceuticals initiated a voluntary precautionary recall of its desmopressin nasal spray products. From the WebMD Archives. Ferring US – Recall of desmopressin nasal spray products • On August 5, 2020, Ferring Pharmaceuticals announced a voluntary, consumer-level recall of several lots of DDAVP ®, desmopressin acet ate, and Stimate ® nasal spray products 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. RECOMMENDATION: Patients, wholesalers, retailers, hospitals or institutions with Lot# NJ4501 and an expiration date of July 2020, should stop use and distribution of the remaining units and quarantine immediately. Desmospray® 0.1 mg/ml Nasal Spray PL 03194/0024 ; These out of specification results were obtained during routine testing. 22 Jul 2020. 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 . Desmopressin Acetate nasal spray, Sun Pharma, 10 mcg/0.1 mL, 5 mL bottle, NDC 47335-0788-91. At the request of the WFH Coagulation Product Safety, Supply, and Access Committee, Ferring representatives were available to answer questions and provide clarifications on the extent of the product recall. Ferring manufactures Stimate and CSL Behring distributes it. Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts, 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, Recent Recalled Product Photos on FDA's Flickr Photostream. Further investigation reveals that this August recall is the continuation of a global recall of Ferring Pharmaceutical nasal sprays that began in mid-July 2020. It is approved for use in hemophilia A and in mild to moderate Type I von Willebrand's disease with Factor VIII levels greater than 5%. DDAVP Nasal Spray, 2.5 mL/5 mL (2020-07-14) Report a Concern. STIMATE® Nasal Spray Consumer-Level Recall. CLDA number: CLDA (21)A/01 Date issued: 18th January 2021 The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a company-led drug recall for: Instanyl 100mcg nasal spray solution Product Batch number Expiry Date Pack Size First Distributed Instanyl 100mcg Nasal Spray 447055 31/10/2021 1 x 6 single dose containers 14/04/2020 Takeda UK … Zydus did not provide a reason for the shortage. Avadel has Noctiva nasal spray on back order and the company cannot estimate a release date. [1], Noctiva nasal spray is labeled for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void.[1]. DDAVP nasal spray, Ferring, 10 mcg/0.1 mL, 5 mL bottle, NDC 55566-2500-00, Noctiva nasal spray, Avadel, 0.83 mcg/0.1 mL, 3.8 mL bottle, NDC 71758-0106-55, Noctiva nasal spray, Avadel, 1.66 mcg/0.1 mL, 3.8 mL bottle, NDC 71758-0107-55, Stimate nasal spray, CSL Behring, 150 mcg/0.1 mL, 2.5 mL bottle, NDC 00053-6871-00, Desmopressin Acetate nasal spray, Amring Pharmaceuticals, 10 mcg/0.1 mL, 5 mL bottle, NDC 69918-0501-05, Desmopressin Acetate nasal spray, Bausch Health, 10 mcg/0.1 mL, 5 mL bottle, NDC 24208-0342-05, Desmopressin Acetate nasal spray, Zydus, 10 mcg/0.1 mL, 5 mL bottle, NDC 68382-0384-01. Aug 11, 2020 3:05 PM Ferring Pharmaceuticals US is recalling the following desmopressin nasal spray products for possible superpotency identified during routine product testing. These out of specification results were obtained during routine testing. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Lexi-Drugs Online. Mar 26, 2004. Ferring Pharmaceuticals Inc. is initiating a precautionary voluntary recall of all batches of Stimate® Nasal Spray (desmopressin acetate) 1.5 mg/mL. Sun Pharma have desmopressin acetate nasal spray available. Contact us at 201-447-2020 or connect with us online to learn about how we can provide you with Desmopressin Acetate Nasal Spray. DDAVP® Nasal Spray 10 mcg/0.1mL Consumer-Level 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. During testing of a sample of desmopressin acetate nasal spray solution product marketed outside the US, a low volume was observed and the analysis of the On August 5, 2020, Ferring Pharmaceuticals announced a recall of three nasal sprays due to superpotency of the ingredients. On August 5, 2020, Ferring Pharmaceuticals announced a recall of three nasal sprays due to superpotency of the ingredients. July 20, 2020. These out of specification results At the request of the WFH Coagulation Product Safety, Supply, and Access Committee, Ferring representatives were available to answer questions and provide clarifications on the extent of the product recall. Manufactured and marketed by Mattrix Initiatives as a homeopathic remedy, Zicam quickly became a popular choice for anyone suffering with sneezes, coughs and a runny nose. 8/12/2020. Healthcare Professionals in your organization should be informed of this recall. 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. Amring (the generic division of Ferring) has desmopressin nasal spray on back order and the company cannot estimate a release date. 8/12/2020. [1], Desmopressin nasal spray 10 mcg/actuation is labeled for use as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and children 4 years of age and older. Audience: Patient, Pharmacy, Health Professional. Safety Alerts, DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL, An official website of the United States government, : About this Recall: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 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. Zicam, was designed to be just that—an over-the-counter remedy, introduced in a nasal spray, that would relieve symptoms associated with colds and influenza. 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 … At Magellan Rx Management, we want to help you get the best possible care. Stimate is marketed as Octim Nasal Spray in Europe and Octostim in Canada. DDAVP Nasal Spray, 2.5 mL/5 mL (2020-07-14) Report a Concern. Audience: Pharmacists and consumers. By Valarie Basheda. On August 11, 2020, Ferring Pharmaceuticals issued a consumer-level recall of all lots on the market of DDAVP® Nasal Spray 10 mcg/0.1mL NDC # 55566-2500-00. CBS reported DDAVP and Desmopressiin Acetate are used as antidiuretic replacement therapices used in managing central cranial diabetes insipidus after head trauma or surgery in the pituitary region. In August 2020, Ferring recalled DDAVP nasal spray, desmopressin nasal spray, and Stimate nasal spray due to higher desmopressin amounts than specified. ocean nasal spray recall 2020. Propharma, Inc., Miami, Florida issued a recall of Major Twice-A-Day 12 Hour Nasal Spray (Lot #K4496, Exp 10/06) because the lot was contaminated with Burkholderia cepacia bacteria. for Recall: Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits. 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. 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. Bausch Health did not provide a reason for the shortage. In mid-August, the European Haemophilia Consortium (EHC) communicated an international recall of all FerringPharmaceuticals Limited nasal sprays containing desmopressin, including Octim®, Octostim®, Desmospray®, DDAVP Spray® and Stimate®, and reported that this may lead to shortages over the course of 2020. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Date: 10 July 2020. Desmopressin. On August 12, 2020, CSL Behring issued a consumer-level recall of all lots on the market of STIMATE® Nasal Spray 1.5 mg/mL NDC # 00053-6871-00 manufactured by Ferring Pharmaceuticals and distributed and sold by CSL Behring. For more information, call 1-888-FERRING (1-888-337-7464); visit www.FerringUSA.com, More Recalls, Market Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles. T&C Compounding are national leaders of specially formulated treatments and offer alternative solutions for patients affected by the Stimate® Nasal Spray Recall.. The decision was taken after an analysis showed that the batch did not conform to … Update on the Recall of Desmopressin Nasal Sprays. Zicam, was designed to be just that—an over-the-counter remedy, introduced in a nasal spray, that would relieve symptoms associated with colds and influenza. Rhinaris Nasal Spray (2020-11-19) Report a Concern. The .gov means it’s official.Federal government websites often end in .gov or .mil. To date, Ferring has not received an increase in adverse event reports due to increased concentrations of desmopressin from users of the nasal spray. Desmospray® 0.1 mg/ml Nasal Spray PL 03194/0024 ; Ferring manufactures Stimate and CSL Behring distributes it. Burg Simpson recently reported on the August 5, 2020 recall of super potent nasal sprays that were manufactured by Ferring Pharmaceuticals and sold in the United States. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. 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 Identification number: RA-73575. 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. In the United States, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and orthopaedics. August 5, 2020 - Ferring Pharmaceuticals announced a voluntary, consumer-level recall of several lots of DDAVP®, desmopressin acetate, and Stimate® nasal spray products due to superpotency or amounts of desmopressin higher than specified. This product is a nasal decongestant containing the active ingredient oxymetazoline hydrochloride 0.05%. CSL Behring has Stimate nasal spray on back order and the company estimates the product will not be available until 2022. Ferring manufactures Stimate and CSL Behring distributes it. September 1, 2020 Ohio Legal Updates, Ohio Products Liability. 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. Updated January 19, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. Stimate® Nasal Spray is indicated for the treatment of patients with mild to moderate classic von Willebrand’s disease (Type I) with Factor VIII levels greater than 5%. Withdrawals, & Find the same product recall information on Target's Facebook page. 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 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. 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