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Neptune's Fix Tianeptine Tablets (Neptune Resources) – Unapproved Drug (2024)

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

Class I

FDAJan 12, 2024Nationwide• Neptune Resources, LLC

Red-E Tablet (Protein Shoppe) – Sildenafil Contamination (2020)

Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.

Class I

FDASep 1, 2020

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Neptune's Fix Tianeptine Tablets (Neptune Resources) – Unapproved Drug (2024)

Red-E Tablet (Protein Shoppe) – Sildenafil Contamination (2020)

TT Side Head Regulator (Life Rising) – Lead Contamination (2016)

Metformin ER Tablets (Shamrock) – Incorrect Release Labeling (2011)