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Home Medical News State & National News Warning!! - Unapproved Nitroglycerin Tablets
Warning!! - Unapproved Nitroglycerin Tablets PDF Print E-mail
State and National News
Written by MM Team   
Sunday, 21 March 2010 13:25
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Warning!! - Unapproved Nitroglycerin Tablets
Warning - Nitro Tablets
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Warning
: FDA orders the marketing of two unapproved Nitroglycerin Tablets stopped!

Nitroglycerin tablets, commonly used to relieve chest pain most typically due to heart aliment's, are administered by placing them under the tongue. 

At this point, you just might be asking yourself  "are my nitro tablets okay?"



It appears that it is uncertain if your NitroGlycerin Tablets are safe, if produced by the 2 companies in question.  The 2 companies are Glenmark Generics of Mahwah, New Jersey and Konec Inc. of Tucson, Arizona. Both have been given a 15 day period of time to respond to the FDA and are allowed to proceed with production for 90 more days and ship for 180 days.
You are urged to speak to your Healthcare Professional for insight. We at MedicalMile.com recommend you speak with your Doctor.

The FDA does not anticipate a supply problem for these products. Pfizer Inc. markets FDA-approved sublingual nitroglycerin tablets in the same strengths and is able to supply the market with approved products. The FDA also will work with patient organizations and health care professionals to ensure that they are aware that an approved product is available.

“Doctors and patients should know that not all drugs on the market are backed by an FDA approval,” said Deborah M. Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research (CDER). “This lack of approval undermines the FDA’s efforts to ensure that safe and effective drug products are available to the American public.”

The next page offers comprehesive Q & A's about the stop order.



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