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The Food and Drug Administration (FDA) informs the public that FDA Advisory No. 2023-1298 or “Public Health Warning on the Presence of Tadalafil in BRAVO Maca + Jatropha + Corynaea Crassa Food Supplement for Men” dated 07 June 2023 is hereby lifted.

After the conduct of monitoring by the FDA-Field Regulatory Operations Office and due evaluation of the submitted documents of the Market Authorization Holder, the requirements for the termination of the mandatory recall has been satisfactorily met in accordance with FDA Circular No. 2016-012, known as the “Guidelines on Product Recall”.

The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders if it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

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