Safety Alerts & Recalls

What does this mean?

At this time, there have not been any reports of health problems associated with this recalled product. However, since the tablets in these recalled lots do not meet the manufacturer's standard for dissolving, the tablets may not dissolve properly in the body and result in patients receiving a lower or higher dose than expected. If you are taking PREMPRO, look at your prescription to see if you are taking PREMPRO 0.3 mg/1.5 mg from an EZ-DIAL dispenser and find the lot number. If your container has a lot number printed on it that matches one of the lot numbers listed in the recall, you should return it to your pharmacy to examine and possibly exchange. If you are not sure if your medicine is involved in the recall or cannot find a lot number, please take your container to your pharmacist for them to check as soon as possible.

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 PREMPRO or any other medicine, please follow up with your doctor.

Recall of Several Lots of PREMPRO 0.3 mg/1.5 mg EZ-DIAL Dispensers

Wyeth Ayerst Laboratories has voluntarily recalled three lots of PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) 0.3 mg/1.5 mg EZ-DIAL Dispensers. PREMPRO is commonly used as hormone replace therapy in postmenopausal women. These tablets are being recalled because they failed tests that measured their ability to dissolve. The following lot numbers have been recalled: Lot D57070, exp September 2010

Lot C95001, exp. July 2010

Lot C18404, exp. March 2010

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

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