Safety Alerts & Recalls

What does this mean?

Although this is not a recall alert, the safety of unapproved drugs is unknown and you should review your nitroglycerin prescription to see if is involved in this FDA warning. This warning only applies to people taking nitroglycerin 0.3 mg, 0.4 mg, and 0.6 mg tablets made by Glenmark Generics and Konec Inc.

If you are taking nitroglycerin 0.3 mg, 0.4 mg, and 0.6 mg tablets, look at your bottle to see if it was made by one of the companies involved in the warning. The manufacturer is also often listed on the prescription label. If you are using the unapproved products, you should continue taking your medication as directed by your doctor and consult your pharmacist or other healthcare professional for help with finding replacement treatment options.

If you think you are experiencing side effects from nitroglycerin or have other concerns about this warning, please follow up with your doctor or other healthcare provider.

FDA Warns Companies to Stop Producing Unapproved Nitroglycerin

The U.S. Food and Drug Administration (FDA) has ordered Glenmark Generics and Konec Inc. to stop marketing unapproved nitroglycerin tablets. The tablets are placed under the tongue to relieve chest pain or to stop a heart attack and are marketed in 0.3 mg, 0.4 mg, and 0.6 mg dosages.

The unapproved nitroglycerin tablets have not been proven safe and effective, and the FDA has not reviewed the quality and labeling of these products. The FDA has seen significant quality and efficacy problems with some unapproved nitroglycerin products.

The FDA does not anticipate a supply problem for nitroglycerin products. Pfizer Inc. makes FDA-approved sublingual (under the tongue) nitroglycerin tablets in the same strengths and is able to supply the market with approved products. No other nitroglycerin products are involved in this warning.

To view the FDA's "Questions and Answers for Consumers" about Unapproved Nitroglycerin Sublingual Tablets, please visit: more information here

For more information from the FDA, please visit: more information here

Source: FDA
Publication Date: 2010-03-17
Last Updated: 2010-03-17

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