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Aurobindo Pharma Adds to Nationwide Valsartan Blood Pressure Medication Recall
americanpharmaceuticalreview
January 14, 2019
Aurobindo Pharma is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of .....
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The valsartan carcinogen mess taught pharma a surprise manufacturing lesson. Will 2019 bring more?
fiercepharma
December 20, 2018
Industry wisdom is that there is nothing new to learn about tablet making. Drugmakers have been doing it essentially the same way for more than 100 years.
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FDA Warns API Manufacturer Involved In Valsartan Recall
americanpharmaceuticalreview
December 13, 2018
The U.S. Food and Drug Administration (FDA) released a warning letter issued to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou Zhejiang China.....
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China's Zhejiang Huahai lambasted in FDA warning letter for putting profits ahead of safety
fiercepharma
December 12, 2018
Instead, the FDA says Huahai accepted the returned batches, then “reprocessed and released [them] to customers in non-U.S. markets.”
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Mylan recalls all lots of blood pressure drugs containing valsartan
pharmaceutical-technology
December 10, 2018
Mylan has expanded the consumer-level voluntary recall of all lots of valsartan-containing drugs within expiry in the US after finding trace amounts of an impurity called N-nitrosodiethylamine (NDEA).....
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FDA updates on voluntary valsartan recalls
europeanpharmaceuticalreview
November 26, 2018
The FDA has provided guidance on valsartan recalls that have been occuring recently, providing lists of drugs affected, and methods of impurity testing…
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FDA Issues Update on Valsartan Recalls
americanpharmaceuticalreview
October 15, 2018
FDA is posting a redeveloped combined gas chromatography-mass spectrometry (GC/MS) headspace method for detecting the presence of impurities N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) in valsartan drug products.
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FDA corrects previous word on embattled valsartan maker's ban
fiercepharma
October 12, 2018
After Zhejiang Huahai Pharmaceutical’s tainted valsartan API triggered a global recall, the FDA slapped an import ban on the drugmaker. But the agency made a confusing mistake in announcing the move—a mistake it just corrected.
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Litigation teaches Chinese valsartan maker the downside of U.S. market
fiercepharma
October 10, 2018
China’s Zhejiang Huahai Pharmaceutical for years enjoyed the upside of the U.S. pharmaceutical market, selling its valsartan API to drugmakers producing blood pressure meds for the market.
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Torrent Pharmaceuticals Issues Recall of Valsartan / Amlodipine / HCTZ Tablets
americanpharmaceuticalreview
August 21, 2018
Torrent Pharmaceuticals is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient.....