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A recall has been ordered for a high-profile diabetes drug after producers discovered it contained alarmingly high levels of a cancer-causing impurity. Marksans Pharma Limited has recalled ...
In February 2020, the FDA found NDMA levels in some tested metformin samples that did not exceed the acceptable daily intake. [143] [144] In February 2020, Health Canada announced a recall of Apotex immediate-release metformin, [145] followed in March by recalls of Ranbaxy metformin [146] and in March by Jamp metformin. [147]
Diversion, abuse, and a relatively high rate of overdose deaths in comparison to other drugs of its group. This drug continues to be available in most of the world including the US, but under strict controls. Terfenadine (Seldane, Triludan) 1997–1998 France, South Africa, Oman, others, US Prolonged QT interval; ventricular tachycardia [2] [3]
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
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Generic drug manufacturers often change the way in which prescription drug ingredients are made in order to lower costs of making them, so this kind of contamination may be more widespread and undetected in generic drugs. [21] 2022–2023 United States P. aeruginosa outbreak in eye drops
The Food and Drug Administration has announced a recall for thousands of bottles of the antidepressant duloxetine, sold under brand names like Cymbalta, due to the presence of a chemical that can ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.