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 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 on the dispenser on the outer packaging. 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 who has made your medicine, 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, please contact your doctor as soon as possible.

Recall of Two 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. The following lot numbers are being recalled because they failed tests that measured their ability to dissolve: Lot C83323 (EXP March 2010)

Lot D82196 (EXP December 2010)

For more information, please visit: more information here

Source: FDA
Publication Date: 2010-02-19
Last Updated: 2010-02-22

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