The Rwanda Food and Drugs Authority (RFDA) has recalled and banned the importation of a drug used to treat epilepsy and bipolar disorder in both adults and children, citing quality deficiencies.
In a circular sent to various stakeholders including central medical stores, Rwanda Medical Supply (RMS) branches, pharmaceutical wholesalers, importers, retail pharmacies, public and private health facilities, and health professionals, the Rwanda FDA outlined its decision.
The drug in question, manufactured by 4Care Lifescience Pvt Ltd/India – an Indian pharmaceutical company, comes in two forms: Gastro-Resistant sodium valproate tablets BP 300mg and Gastro-Resistant sodium valproate tablets BP 500mg.
While the UK National Health Service states that this medicine, used to treat epilepsy and bipolar disorder, is exclusively available by prescription and occasionally used for preventing migraine headaches, the Rwanda FDA found that the batches it examined did not meet the required quality standards.
The recall of certain batches had been initiated on January 27, 2023, and further investigations and laboratory quality control analyses were subsequently conducted on additional reported batches. These analyses confirmed that the medicine failed to meet quality standards across all batches nationwide.
The quality issue identified with the implicated tablets is their tendency to become semi-solid and cracked.
As a result, the Rwanda FDA has instructed importers, central medical stores, wholesalers, RMS branches, retailers, and public and private health facilities to cease the distribution of all batches of the affected tablets. They are also required to return the products to their respective suppliers for appropriate management.
Importers and suppliers of the medication are requested to report the quantities imported, distributed, returned, and the final stock on hand to the Rwanda FDA within 10 days from the publication date of this recall notice (May 31).
The Rwanda FDA will officially communicate when the importation of the medication will be allowed again, after the mentioned products have undergone registration.