NAFDAC Warns of Counterfeit Herceptin® in Ghana; Traced Back to Nigeria

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Published by Rosemary Osuoha, PharmD.
Last updated on july 3, 2025
How the Alert Unfolded | Health Risks | About Herceptin

The National Agency for Food and Drug Administration & Control (NAFDAC) has issued Public Alert No. 22/2025, warning healthcare providers and the public of a confirmed case of counterfeit Herceptin® 600 mg/5 ml vials (trastuzumab for injection) circulating in Ghana, with the counterfeits reportedly originating from Nigeria.

How the Alert Unfolded

Ghana’s Food and Drugs Authority (FDA-Ghana) released Medical Product Alert No. 03/2025 after Roche Products Ghana Ltd. confirmed the presence of falsely labelled Herceptin® (batch A8519) in a Kumasi hospital.

The counterfeit product did not match any genuine Roche batches and bore packaging inconsistencies, including wrong fonts, misaligned labels, and irregular tamper-evident seals.

A patient who received the suspect vial reported purchasing it in Nigeria, prompting an urgent investigation.

Health Risks and Packaging Flaws

  • Lack of active drug: The counterfeit may contain substandard or no trastuzumab, compromising breast cancer treatment and risking disease progression.
  • Unknown contaminants: The falsified formulation may pose serious health threats, including immune reactions or systemic toxicity.
  • Packaging alerts: Identified discrepancies include the unrecognized batch number A8519, font and layout errors, and tamper-seal mismatches.

About Herceptin® (trastuzumab)

Herceptin® is a monoclonal antibody used to treat HER2-positive breast cancer, both in early and metastatic stages. It works by inhibiting the proliferation of cancer cells that overexpress the HER2 protein.

What Patients & Providers Should Do

  • Only obtain Herceptin® from recognized pharmacies and formal healthcare providers.
  • Inspect packaging closely—verify batch numbers, seal integrity, font consistency, and cross-check with manufacturer records. Suspicious products should not be used.
  • Report any suspect vials or adverse reactions immediately to regulatory authorities via: