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Ensuring the Rigor of Regulatory Science: CDER Conducts Laboratory and Clinical Studies to Investigate Reports of NDMA Production from Ingested Ranitidine Products
fda.gov
July 12, 2021
Ranitidine, which blocks histamine-induced acid secretion in the stomach, was approved in 1983.
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Pfizer halts distribution of anti-smoking drug after finding carcinogen
expresspharma
June 28, 2021
The US drug regulator has, in the past, reached out to companies whose drugs had N-nitrosodimethylamine (NDMA) over accepted levels.
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Nostrum Expands Recall Metformin HCl Extended-Release Tablets
americanpharmaceuticalreview
February 03, 2021
Nostrum Laboratories is voluntarily recalling one lot of Metformin HCl Extended-Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level.
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Nostrum Laboratories Expands Recall of Metformin HCl Extended Release Tablets
americanpharmaceuticalreview
January 20, 2021
Nostrum Laboratories is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level.
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Nostrum Laboratories Issues Recall of Metformin HCl Extended Release Tablets
americanpharmaceuticalreview
November 06, 2020
Nostrum Laboratories is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 500 mg to the consumer level.
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Sun Pharma, Strides Pharma recall drugs in the US
expresspharma
October 12, 2020
Sun Pharma is recalling 747 bottles of generic diabetes drug due to higher levels of NDMA while Strides Pharma is recalling 11,280 bottles of potassium chloride extended-release tablets due to failed dissolution specifications.
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Marksans Pharma and Sun Pharma voluntarily recall metformin
expresspharma
October 10, 2020
FDA publishes a recalled metformin list including details about metformin products that have been recalled.
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Sun Pharma recalls metformin due to high NDMA levels
expresspharma
September 27, 2020
NDMA is classified as a probable human carcinogen based on results from laboratory tests.
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Bayshore Voluntarily Recalls Extended Release Metformin
americanpharmaceuticalreview
August 25, 2020
The U.S. Food and Drug Administration (FDA) is alerting patients and health care professionals to Bayshore Pharmaceuticals’ voluntary recall of two lots of extended release (ER) metformin (one lot of 750 mg tablets and one lot of 500 mg tablets).
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Bayshore Issues Voluntary Nationwide Recall of Metformin Hydrochloride
americanpharmaceuticalreview
August 24, 2020
Bayshore Pharmaceuticals is voluntarily recalling one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, 1000 count bottles and one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 count bottles within ...