We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Mylan NV | NASDAQ:MYL | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 15.855 | 15.71 | 15.90 | 0 | 01:00:00 |
HERTFORDSHIRE, England, and PITTSBURGH, Jan. 8, 2020 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, USP (including the 150mg and 300mg strengths). While Mylan has not received any reports of adverse events related to these batches to date, this product is being voluntarily recalled due to detected trace amounts of an impurity N-nitrosodimethylamine (NDMA) contained in the API Nizatidine, USP, manufactured by Solara Active Pharma Sciences Limited.
NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. NDMA has been classified as a probable human carcinogen (a substance that could cause cancer) according to the International Agency for Research on Cancer (IARC).
The finished products are manufactured by Mylan Pharmaceuticals Inc. These batches were distributed nationwide to wholesalers, mail order pharmacies, retail pharmacies, and a distributor between June 2017 and August 2018. The recalled batches are as follows:
NDC | Product Description | Strength | Size | Lot Number | Expiry |
0378-5150-91 | Nizatidine Capsules, USP | 150mg | Bottles of 60 | 3086746 | May 2020 |
0378-5300-93 | Nizatidine Capsules, USP | 300mg | Bottles of 30 | 3082876 | Jan 2020 |
0378-5300-93 | Nizatidine Capsules, USP | 300mg | Bottles of 30 | 3082877 | Jan 2020 |
Nizatidine is indicated for the short-term treatment (up to 8 weeks) of active duodenal ulcers and active benign gastric ulcers, as maintenance therapy for duodenal ulcer patients for up to one year, and for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).
Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Wholesalers, retailers and consumers that are in possession of recalled product should contact Stericycle at 888-628-0727 for the return of the recalled product. Normal business hours are Monday through Friday 8 a.m. to 5 p.m. EST.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.
View original content to download multimedia:http://www.prnewswire.com/news-releases/mylan-initiates-voluntary-nationwide-recall-of-three-lots-of-nizatidine-capsules-usp-due-to-the-detection-of-trace-amounts-of-ndma-n-nitrosodimethylamine-impurity-found-in-the-active-pharmaceutical-ingredient-manufactured-by-s-300983578.html
SOURCE Mylan N.V.
Copyright 2020 PR Newswire
1 Year Mylan NV Chart |
1 Month Mylan NV Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions