AvKARE Recalls Sildenafil and Trazodone

December 9, 2020 – AvKARE of Pulaski, TN, has voluntarily recalled one lot of Sildenafil 100mg tablets and one lot of Trazodone 100mg tablets after the two products were inadvertently packaged together during bottling at a third-party facility.

Sildenafil is used to treat erectile dysfunction, while trazodone is indicated to treat major depressive disorder. Inadvertent consumption of sildenafil may lead to serious drug interactions in patients taking certain prescription medications. These interactions can cause dangerously low blood pressure. Patients at high risk of these interactions include those taking medication for high blood pressure, heart disease, and diabetes. For patients who inadvertently take trazodone, potential adverse events include sedation, dizziness, constipation, and blurred vision.

As of the date of the recall, AvKARE has not received any reports of adverse events related to the affected medication lots. Consumers can contact AvKARE with questions regarding the recall at 1-855-361-3993 and should contact their healthcare provider if they experience any problems that may be related to use of the affected medications. Adverse events can also be reported to the U.S. FDA’s MedWatch program.

The full recall notice is available on the FDA's website.

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