The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a warning about the circulation of counterfeit versions of Phesgo 600mg, a drug used in the treatment of breast cancer.
This was disclosed in a public notice issued by the agency.
According to the alert, the counterfeit products were reported by the Lagos University Teaching Hospital (LUTH-NSIA), where patients presented suspected fake Phesgo injections for administration.
What NAFDAC said
NAFDAC said the Marketing Authorization Holder, Roche, received complaints involving suspected counterfeit batches B2346B16 and C3809C5.
- “The batch C3809C5 vial volume was observed to be approximately 20mL instead of the expected 10mL. Both products were reported to be brought in by patients for administration.
- Only pictures of the complaint samples were sent to Roche by the complainants for investigation. Although a complete investigation was not possible, the pictures provided were scrutinized by Roche and compared to genuine retained samples,”they stated.
Roche’s investigation identified the following discrepancies when compared with genuine products.
- A non-existent batch number in their database,
- Incorrect text
- Incorrect variable data
- The GTIN does not correspond to any genuine GTIN
- The tamper-evidence label was missing
- Significant differences in packaging material compared to the genuine product.
NAFDAC also revealed that batch number B2346B16 has been linked to confirmed counterfeit cases in multiple countries, including Nigeria, Turkey, and the Philippines.
More details
Phesgo 600mg (Pertuzumab/Trastuzumab) is a critical drug used in the treatment of breast cancer. It works by targeting and stopping the growth of cancer cells.
- The agency warned that counterfeit medicines pose serious health risks, as they do not meet required standards for safety, quality, and effectiveness.
- NAFDAC has directed all zonal directors and state coordinators to intensify surveillance and remove the counterfeit products from circulation.
- Healthcare providers, distributors, and retailers have also been advised to source medicines only from authorised suppliers and carefully verify product authenticity before use.
Consumers and healthcare professionals are urged to report suspected counterfeit medicines to NAFDAC through its official channels.
What you should know
NAFDAC has continued to intensify its alerts and enforcement actions against unsafe and falsified medical products in Nigeria.
In a recent notice, the agency warned about the recall of MR.7 SUPER 700000 male enhancement capsules after the product was found to contain undeclared pharmaceutical ingredients, posing serious health risks to consumers.
- In another safety alert, NAFDAC recently directed the immediate withdrawal of multi-dose Artemether/Lumefantrine dry powder for oral suspension still in circulation across the country.
- The agency also flagged a suspected revalidated SMA Gold infant formula discovered in Kaduna State after altered expiry dates were linked to illness in a four-month-old infant.
Another is on the circulation of falsified Dostinex 0.5mg tablets in Nigeria. The legitimate product is registered but not yet imported, while the fake batches, GG3470, LG8659, and GG2440, have no NAFDAC registration and may be unsafe
