NAFDAC Warns Against Counterfeit Phesgo® 600mg/600mg/10ml Injection

NAFDAC Warns Against Counterfeit Phesgo® 600mg/600mg/10ml Injection

Lagos, Nigeria – The National Agency for Food and Drugs Administration and Control (NAFDAC) has issued a public alert regarding counterfeit Phesgo® 600mg/600mg/10ml injection labelled with batch number C5290S20, falsely stated to be manufactured by Roche S.P.A.

The warning follows a complaint from a Lagos University Teaching Hospital (LUTH-NSIA) doctor about the suspected counterfeit product presented by a patient.

Roche, the Marketing Authorisation Holder (MAH), reviewed the product’s images and confirmed it as counterfeit due to discrepancies, including:

  • Non-existent batch number in Roche’s database.
  • Language inconsistencies.
  • Incorrect tamper evidence labels and missing safety features.

No physical sample was available for chemical analysis.

NAFDAC Warns Against Counterfeit Phesgo® 600mg/600mg/10ml Injection

Product Risks

Counterfeit medicines, like the falsified Phesgo®, pose severe health risks, compromising safety, quality, and effectiveness.

Counterfeit Product Details:

  • Product Name: Phesgo® 600mg/600mg/10ml Injection
  • Manufacturer (Claimed): Roche S.P.A
  • Correct Manufacturer: F. Hoffmann-La Roche Ltd., Switzerland
  • Batch No.: C5290S20
  • Manufacturing Date: 01/2024
  • Expiry Date: 01/2026

Phesgo® is primarily used in breast cancer treatment.

NAFDAC Warns Against Counterfeit Phesgo® 600mg/600mg/10ml Injection

NAFDAC has directed surveillance and mop-up operations to eliminate the counterfeit product from circulation.

Advisory to Healthcare Providers and Consumers

  • Obtain medicines from authorized suppliers.
  • Verify product authenticity and physical condition.
  • Report suspected counterfeit products to NAFDAC via 0800-162-3322, email at sf.alert@nafdac.gov.ng, or the Med-Safety app.

This alert will also be submitted to the WHO Global Surveillance and Monitoring System (GSMS).