To gain approval to manufacture and distribute a generic drug, manufacturers are required to develop formulas of the identical active ingredients used in the branded product and must demonstrate bioequivalence to the brand under strict U.
FDA guidelines. At Amneal, we have a team dedicated to ensuring bio-equivalence of all our generic products. We also take quality very seriously. Learn more about what goes into making high-quality Amneal medications. Amneal makes no claims regarding the kosher status of its products.
For kosher considerations, patients should consult their spiritual leader and physician for guidance. Amneal maintains an extensive product listing on our web site. The catalog features all the Amneal and Impax products currently being sold as well as discontinued products still available in the marketplace.
If you cannot find the answers you need from the product information or references, our Customer Response team is ready to assist. For information about an Amneal product , call toll-free, or email customerresponse www.
Epinephrine Auto-injector. We use cookies for statistical and measurement purposes, to help improve our website and to allow us and our partners to provide you with more relevant information. By continuing to navigate this site, closing this box, or by clicking here you are indicating your consent to our use of cookies. Revoke cookies. Risk Statement : NDMA is classified as a probable human carcinogen a substance that could cause cancer based on results from laboratory tests.
NDMA is a known environmental contaminant found in water and foods, including meats, dairy products and vegetables. Metformin HCl Extended Release Tablets, USP, mg and mg, manufactured by Amneal, are prescription, solid oral products that are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
Amneal is notifying its direct customers via mail UPS Standard Overnight by mailing a recall notification letter and is arranging for return of all the recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from Amneal may call Amneal at or email to AmnealProductRecallDS amneal. Pharmacies should cease dispensing product.
If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Amneal Drug Safety by phone at , Monday - Friday, am — pm, EST, or via e-mail at DrugSafety amneal.
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