IGMPI India

Eugene Oregon Inc. has issued a voluntary recall of all lots of African black ant, Black ant and Mojo risen dietary supplements to the consumer level. The recall was initiated in the beginning of this month. It is revised to reflect the recall of all lots of the recalled products.

The products were recalled after the FDA analysis of these products distributed to the third party. The analysis revealed that the distributed products contained undeclared amounts of the active pharmaceutical ingredients Sildenafil and Tadalafil. Sildenafil and Tadalafil are FDA approved pharmaceutical ingredients used to treat erectile dysfunction. This recall is being executed as a precautionary measure.

Sildenafil and tadalafil can cause threat to consumers as they can interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Patients/ consumers with diabetes, high blood pressure, high cholesterol, and heart disease often take nitrates. Till date company has not received any reports of adverse events related to the recall.

The recalled products are marketed as dietary supplements and packaged in tins, envelopes, and/or boxes and were distributed to consumers nationwide at retail stores. The company has discontinued the distribution of these products. The recall is being conducted with the knowledge of the US Food and Drug Administration.