Safety Alerts & Recalls

What does this mean?

This recall for Isosorbide Mononitrate Extended-Release Tablets, 30 mg and Ismo Tablets (Isosorbide mononitrate) 20 mg was issued at a warehouse and pharmacy level only. The FDA and companies involved have determined that any recalled product that may have been dispensed to patients does not pose a significant health risk. However, if you take Isosorbide Mononitrate Extended-Release Tablets, 30 mg, you may wish to check your medicine. If any of your tablets bigger than normal or if they look different than what you normally receive, take your prescription to your pharmacist to examine.

If you have any concerns about this recall alert or your medicine, please follow up with your doctor or pharmacist.

Two Companies Recall Their Isosorbide Mononitrate Product

Schwarz Pharma Manufacturing, Inc. have recalled two lots of Isosorbide Mononitrate Extended-Release Tablets, 30 mg. Lot numbers 0913001 and 0913002 have been recalled because these lots contained thicker and overweight tablets.

In a separate recall notice, Promius Pharma, LLC recalled two lots of Ismo Tablets (Isosorbide mononitrate) 20 mg made by West-ward Pharma, LLC. Lot number 62519A and 66948A have been recalled because these lots failed the manufacturer routine tests that measure the tablets' ability to dissolve.

Isorsorbide is used in the treatment of chest pain and other heart related conditions. Isosorbide is available under many different formulations and brand names. This recall alert only applies to these select products by Schawrz Pharma Manufacturing, Inc and Promium Pharma, LLC. No other isosorbide products were involved in this recall.

To view the FDA notice about this recall, please visit: more information here

Source: FDA
Publication Date: 2010-07-21
Last Updated: 2010-07-24

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