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US FDA asks five firms to recall diabetes drug with high NDMA levels
expresspharma
May 29, 2020
It named Apotex Corp as one of the firms whose metformin tablets have high levels of NDMA, but did not reveal the other four firms.
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Ranitidine Banned again after being Removed from the U.S. Market: Will a Chain Reaction be in China?
PharmaSources/Laoxue
May 21, 2020
The Committee for Medicinal Products for Human Use (CHMP) under the EMA has recommended the suspension of all ranitidine drugs in the EU on Apr. 30.
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A Prospect of Ranitidine Market Changes under the Expanding Influence of Genotoxic Impurities
PharmaSources/zhulikou431
April 22, 2020
The U.S. FDA released the FDA Updates and Press Announcements on NDMA in Zantac (ranitidine) on April Fools’ Day to explain the change characteristics of the genotoxic impurities in ranitidine products and request all ranitidine manufacturers to remove su
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Amneal recalls three nizatidine lots due to potential NDMA contamination
europeanpharmaceuticalreview
April 21, 2020
The FDA has said that Amneal Pharmaceuticals is recalling three lots of nizatidine oral solution at the consumer level due to potential NDMA contamination.
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US FDA calls for removal of all ranitidine products
expresspharma
April 03, 2020
New studies show NDMA impurity increases in some meds over time, and when stored at higher than room temperature。
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Online pharmacy finds high levels of NDMA in metformin
europeanpharmaceuticalreview
March 09, 2020
Tests conducted by an online pharmacy has revealed high levels of NMDA in the diabetes drug metformin, prompting the company to press for a recall.
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Online pharmacy Valisure says tests show carcinogen in diabetes drug metformin
expresspharma
March 04, 2020
High levels of N-nitrosodimethylamine (NDMA) were found in metformin made by 11 companies, including Amneal Pharmaceuticals Inc and Aurobindo Pharma Ltd, the company said in a statement.
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American Health Packaging voluntarily recalls ranitidine tablets
europeanpharmaceuticalreview
March 03, 2020
Ranitidine tablets have been recalled due to the possibility of the products containing unacceptable levels of NDMA.
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Lab finds NDMA in Zantac can develop during storage
fiercepharma
January 06, 2020
Another testing lab has jumped into the Zantac impurity fray and urged the FDA to recall all ranitidine drugs.
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EMA update: non-EU metformin medicines contain acceptable levels of NDMA
europeanpharmaceuticalreview
December 11, 2019
The EMA has announced that metformin tablets from outside the EU do not contain unacceptable levels of NDMA impurities and EU metformin is not affected.