Safety Alerts & Recalls

What does this mean?

Since over-sized tablets can lead to side effects caused by receiving too high of a dose if naproxen, this alert should be taken seriously. Side effects of too much naproxen include dizziness, extreme tiredness or drowsiness, stomach pain, heartburn, nausea, or vomiting.

If you take naproxen 500 mg tablets by prescription, check your prescription bottle to see if your tablets were made by Amneal Pharmaceuticals. The manufacturer is often listed on the prescription label. If you think your tablets are involved in the recall, or if you do not know who made your tablets, please return your prescription bottle to your pharmacist to examine and possibly exchange.

If you have any questions or concerns about this recall, please follow up with your doctor or pharmacist. If you think you may be experiencing side effects from naproxen, please contact your doctor as soon as possible.

Single Lot of Naproxen 500 mg Tablets Recalled

Amneal Pharmaceuticals is recalling a single lot of Naproxen 500 mg tablet, available by prescription only. This lot is being recalled because the company has received a report of one over-sized tablet. The lot number involved in this recall is Lot # HC6109, with an expiration date of March 31, 2013 (Exp 03/13).

Naproxen is used to treat minor to moderate pain and inflammation. It is also sold under several brand names such as Aleve. The lot number involved in this recall is only available by prescription. No other brands, strengths, or over-the-counter products of naproxen were involved in this recall.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-10-18
Last Updated: 2009-12-05

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