The National Health Surveillance Agency (ANVISA) announced the prohibition of the distribution of irregular batches of a medication used in the management of multiple sclerosis. The measure was adopted following the identification of inconsistencies in manufacturing and quality control processes of the affected batches.
The decision reaffirms ANVISA's commitment to patient safety and the assurance of quality for pharmaceutical products marketed in Brazil. The agency conducted investigations that found the batches did not meet the criteria established by current health legislation, including Good Manufacturing Practices (GMP).
The prohibited batches must not be distributed, dispensed, or used within Brazilian territory. ANVISA advises pharmacies, hospitals, and distributors to verify their inventory and contact the competent authorities if they hold units of the affected batches.
This action is part of the pharmacovigilance and inspection activities regularly conducted by ANVISA to monitor the quality and compliance of medications on the market. The agency maintains continuous oversight of pharmaceutical products, especially those used in the management of complex chronic conditions such as multiple sclerosis.
Patients using medications from this class should maintain contact with their prescribers and pharmacists for information about available alternatives and to ensure appropriate ongoing management of their health conditions.
