Mylan N.V. 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 Solara Active Pharma Sciences Limited
January 08, 2020 at 10:30 am
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Mylan N.V. 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). 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. 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.
Viatris Inc. is a global healthcare company. The Company's segments include Developed Markets, Greater China, JANZ, and Emerging Markets. The Developed Markets segment comprises its operations primarily in North America and Europe. The Greater China segment includes its operations in China, Taiwan and Hong Kong. The JANZ segment reflects its operations in Japan, Australia, and New Zealand. The Emerging Markets segment encompasses its presence in more than 125 countries with developing markets and emerging economies, including in Asia, Africa, Eastern Europe, Latin America, and the Middle East, as well as the Companyâs ARV franchise. The Companyâs portfolio comprises approved molecules across a range of key therapeutic areas, including globally recognized iconic and key brands and generics, including complex products. The Company operates manufacturing sites across worldwide that produce oral solid doses, injectables and complex dosage forms.
Mylan N.V. 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 Solara Active Pharma Sciences Limited