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Medication Safety Alerts

Limbrel® Capsules Voluntary Recall

January 30, 2018

On January 30, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding a voluntary recall of Limbrel® capsules manufactured by Primus Pharmaceuticals. This recall was issued because of rare but serious and reversible side effects.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

A complete list of products affected by this recall is provided here:

You should not continue to use product that is affected by this recall. Please call your doctor right away for advice if you may be using affected product or if you do not know if you used affected product or not. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

Please note: This recall affects all unexpired lots of these products so replacement product is not available. To make sure your prescription therapy is not interrupted, please see your doctor for a prescription for a different product to treat your condition.

CVS Caremark Response: If you are currently taking Limbrel capsules and have not discussed this recall with your doctor, please call a Customer Care representative toll-free at 1-866-823-5184. We will give you more information and help with arrangements for the return of any affected product.

If you are currently taking Limbrel capsules and have questions regarding this recall, please call your doctor or call Primus Pharmaceuticals at 1-480-483-1410, Monday through Friday, 9:00 AM to 5:00 PM (MT) or visit www.limbrel.com. You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov/.

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