Texas Metformin Diabetes Drug Recall by Texas Lawyer Jason S. Coomer
THE LAW OFFICES OF JASON S. COOMER IS NO LONGER ACCEPTING OR REVIEWING METFORMIN CASES
A recent FDA alert discusses several companies' voluntary recall of tainted and impure Metformin drugs. Patients should talk to their doctor about their medication plan prior to making any changes. The FDA, health care professionals, and the drug manufacturers are closely monitoring the Metformin situation as it relates to possible contamination. More specifically, some reports show the presence of high levels of nitrosamines in certain diabetes drugs.
See the FDA's May 28, 2020 release regarding their continued investigation into Nitrosamine impurities in drug products for additional information.
Several Manufacturers Recall Extended Release Metformin Drugs By Texas Metformin Lawyer Jason Coomer
Texas Metformin lawyers are aware of the recall of EX Metformin drugs Apotex, Amneal, Marksan, Lupin, and Teva. More specifically, manufacturers have a recall of several batches and lots of these products for potential impurities found in testing. These impurities raise questions regarding potential manufacturing defects in certain metformin drugs. The FDA Notice of this recall alerts patients and health care professional that certain extended release (ER) metformin drugs are potentially unsafe. Further, this recall alerts patients using several specific metformin products to potential carcinogens in the products.
As of July 3, 2020, Granules Pharmaceuticals is announcing the recall of twelve lots of their Metformin Hydrochloride ER diabetes drug. Granules investigation shows nitrosamine levels above the limit that the FDA allows. This was shown in one out of twelve batches here in the United States market. Typically, a manufacturer will work to notify the distributors and customers that could be as risk due to a product recall. Speak to your pharmacy and doctor about the diabetes drug recall. It is best to report any adverse reactions to your healthcare professionals and the FDA. You can make the FDA report online. Further, feel free to contact Texas Metformin lawyer, Jason Coomer for more information regarding a diabetes drug recall lawsuit.
Lupin Pharmaceuticals Recall Extended Release Metformin Drugs By Diabetes Drug Recall Lawsuit Attorney Jason Coomer
As of July 8, 2020, Lupin Pharmaceuticals is announcing the recall of all of their Metformin Hydrochloride Extended-Release Tablets USP, 500mg, and 1000mg diabetes drug. Testing shows some batches contain more than the allowed amount of the contaminate N-Nitrosodimethylamine (NDMA). NDMA is known to probably cause cancer in humans. NDMA is a contaminant found in the environment in water and foods. Lupin is recalling all batches as a cautious measure. Speak to your pharmacy and doctor about the diabetes drug recall.
FDA Issues Testing Method for Metformin Drug Substances and Drug Products Produced Outside the United States
The FDA also provides testing methods for the industry to detect nitrosamine impurities in pharmaceuticals. Further, the FDA encourages the industry and regulators to test international supply chains for impurities. These test methods should test metformin drug substances and drug products for impurities. More specifically, drug companies with supply chains outside the United States should use this test to prevent nitrosamine impurities. These drug manufactures should specifically test APIs and drug products imported into the United States.
Tainted Metformin Diabetes Drug Lawyers File Claims Against Tainted Metformin Manufacturers
A recent tainted metformin lawsuit accuses various generic drug companies of violating Good Manufacturing Practices (cGMP). More specifically, the lawsuit alleges that Arobindo, Aurolife Pharma, Heritage Pharmaceuticals, and Emcure Pharmaceuticals concealed the contamination. Additionally, metformin studies and testing suggest that tainted diabetes drugs may be wide spread. Supply lines for tainted diabetes drugs should be tested and pervasive violations of good manufacturing practices should be stopped. Further, drug companies need to test metformin products to ensure they do not contain high levels of carcinogens.
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