FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Australia’s TGA Issues Warning Over Illegal Capsules

Aug. 14, 2019

Australia’s Therapeutic Goods Administration drug regulator has warned that capsules of the herbal supplement Bali Mojo were found to contain tadalafil, a prescription-only medication for treating erectile dysfunction.

The TGA said the capsules were not assessed by the agency for safety, quality or efficacy, and it had not inspected the manufacturing facility. The agency advised patients to immediately stop using the product.

The company’s website describes the product as containing only organic herbs. The product was flagged by the FDA and other regulatory agencies in previous years over similar concerns.

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