Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg is packaged in 60, 90 and 100 count bottles and was distributed nationwide in the US to wholesalers, distributors, drug chain, mail order pharmacies and supermarkets. Available for Android and iOS devices. After repeated administration of GLUCOPHAGE XR, metformin did not accumulate in plasma. 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.June 05, 2020 -- Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The Metformin Hydrochloride Extended-Release Tablets USP, 750 mg lots subject to the recall is identified in the table below.Metformin Hydrochloride Extended-Release Tablets USP, 750 mgThe affected Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, lots were distributed nationwide in the USA directly to Distributors, and Retailers.

x�b```b``g`c`��d�g@ ~V�(� 0000005708 00000 n Following is a list of possible medication recalls, market withdrawals, alerts and warnings. We comply with the HONcode standard for trustworthy health information - 0000012937 00000 n Company test results showed one of the lots (PY7174) contains a nitrosamine impurity called N-nitrosodimethylamine (NDMA) that increased over time to a level above the acceptable limit. 0000002830 00000 n JAMP Pharma Corporation is voluntarily recalling all 26 lots of its prescription Metformin drug from the Canadian market (Metformin DIN 02380196 [500mg] and Metformin DIN 02380218 [850mg]) as a precautionary measure. %%EOF According to the US Food & Drug Administration, It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.

The Department will take action if a new risk to Canadians is identified, and will continue to inform the public of new safety information. After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. Select one or more newsletters to continue. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 was distributed by Time-Cap Labs, Inc. (located at 7 Michael Avenue, Farmingdale, New York 11735) nationwide in the USA to wholesalers who further distributed to pharmacies.Marksans Pharma Limited is notifying its distributors and customers by issuing notification letter and press release and is arranging for return/replacement etc. 0000013825 00000 n

• Glucophage can be used in children from 10 years of age and adolescents. Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. 0000009802 00000 n Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. Please refer to the Affected products table below for detailed information on the recalled lots. Ranbaxy Pharmaceuticals Canada Inc. is recalling six lots of its prescription RAN-Metformin drug from the Canadian market. 0000002309 00000 n Please visit the agency’s website for more information at Wholesalers, distributors, and retailers that have Metformin Hydrochloride Extended-Release Tablets USP, 500mg which is being recalled should discontinue distribution of the recalled product lot immediately and return it to Inmar Rx Solutions, Inc., 635 Vine St, Winston Salem, NC 27101. %PDF-1.5 %���� 0000004152 00000 n Metformin Hydrochloride Extended-Release Tablets USP, 500mg was distributed nationwide in the USA to wholesalers, distributors, and mail order pharmacies.Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, and mail order pharmacies by phone and through recall notification and is arranging for the return of all the recalled product lot. 0000031162 00000 n 0000008643 00000 n The lots being recalled are packaged under the Actavis Pharma, Inc. label and are contained in the table below.

0000001971 00000 n Please visit the agency’s website for more information at Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the Teva products being recalled should contact Teva Medical Information by phone at: 888-838-2872, option 3, then, option 4. Teva will continue to partner with, and regularly update, all relevant regulatory authorities as relevant information becomes available.June 05, 2020 -- Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in 100 count bottles with NDC code 49483-623-01. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Amneal Pharmaceuticals, Inc. (the “Company”).