It should not be construed to indicate that the use of any medication in any country is safe, appropriate or effective for you. To date, Apotex has not received any reports of adverse events related to use of the product.Metformin Hydrochloride Extended-Release Tablets, USP is a prescription oral product indicated as an adjunct to diet and exercise to improve blood sugar control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Apotex Corp is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg within expiry to retail level.
Metformin XR APOTEX may be available in the countries listed below.Important Notice: The Drugs.com international database is in BETA release. June 05, 2020 -- Apotex is expanding the previously announced Retail Level recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg that was initiated on May 29, 2020 to Consumer Level. We comply with the HONcode standard for trustworthy health information - Apotex Corp has agreed to recall this lot, and out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the US. Apotex stopped selling this product in the US in February 2019, and there remains only limited product on the market.

Wholesalers, Distributors and Retailers should return the recalled product to the place of purchase. Metformin Hydrochloride Extended-Release Tablets, 500MG, 100 TABLET (BOTTLE) It is used … The affected Metformin Hydrochloride Extended-Release Tablets, USP can be identified by NDC numbers stated on the product label. Apotex has recalled all its Metformin Hydrochloride Extended-Release Tablets 500 mg in the United States for too much of carcinogen NDMA, the … Customers who purchased the impacted product directly from Apotex can call Consumers with questions regarding this recall can contact Apotex Corp.  by phone at 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address 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.This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection of N-nitrosodimethylamine (NDMA) Apotex Corp. is in a process of notifying its affected direct account Wholesaler, Distributor, Chain Distribution and Warehousing Chains via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product.
This means it is still under development and may contain inaccuracies. In an increasingly competitive market environment, Apotex continually strives to introduce quality, affordable medicines to consumers. Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Metformin XR APOTEX in the following countries: Australia Important Notice: The … Metformin is indicated in the treatment of type 2 diabetes mellitusin adults, children from 10 years of age and adolescents, particularly in overweightpatients, when dietary management and exercise alone does not result in adequate glycaemic control.. Apotex Inc., a Canadian pharmaceutical corporation, is … Anyone with an existing inventory of the product should quarantine the recalled lots immediately. These extended-release formulations are made by Amneal Pharmaceuticals Inc., Actavis Pharma Inc., Apotex Corp., Lupin Pharma and Marksans Pharma Ltd. Apotex Corp. promptly issued an announcement that it was recalling all lots (batches) of its 500 milligram extended-release metformin, after the FDA notified the company that one lot was found to have elevated levels of NDMA. Available for Android and iOS devices. Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) and recommended recall of the one tested lot. Metformin Hydrochloride Extended-Release Tablets, USPThe affected Metformin Hydrochloride Extended-Release Tablets were distributed nationwide in the USA to Warehousing Chains. Select one or more newsletters to continue.