Recall: Premarin for Menopause Symptoms

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Manufacturer Pfizer Pharmaceuticals has issued a voluntary recall for some brand- name Premarin products. Premarin is a mixture of estrogens used for hormone replacement therapy, and to treat hot flashes and prevent osteoporosis.

This is a class II recall, the most common type of recall, which means that there is a situation where use of the recalled medication may cause temporary or medically reversible health consequences. However, the likelihood of serious adverse effects is small. For more information on the different types of recalls, see our overview here.

Who can recall a drug?

A manufacturer can voluntarily call their medication, or the Food and Drug Administration (FDA) can request or require that a manufacturer recall a particular medication.

In this case, the manufacturer has voluntarily recalled various Premarin products, with the knowledge of the FDA.

Which Premarin Products were affected? 

In this recall, 1 manufacturer, 1 lot and 1 strength were affected.

Drug: Premarin 1.25mg tablets
Manufacturer: Pfizer Pharmaceuticals
Lot: #M35953S
National Drug Code (NDC): 00046-1104-91

If you have any trouble finding the lot and NDC information on your prescription, please check with your pharmacist for more information.

Why has Premarin been recalled?

On November 3rd 2016, Pfizer initiated a recall because of an incorrect expiration date applied to the affected bottle labels. This means that you could be taking expired medication, increasing your risk for experiencing side effects, complications, and decreased efficacy.

Are patients who have taken this medication being notified?

No. This is a class II recall, which means that it isn’t necessary to notify you unless your doctor believes it may have a effect on your health. However, pharmacies with the affected lot in their inventory have been directed to stop distribution and arrange for product return.

If you have concerns that your prescription may be affected, contact your doctor for more information.

Where can I go to lean more information?

At this time, there is little information regarding the Premarin recall.

However, you can visit the Premarin website, or contact Pfizer if you have any further questions.


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