Gambiaj.com – (BANJUL, The Gambia) – The Medicines Control Agency (MCA) of The Gambia has issued an urgent recall of two medicinal products found to be substandard during routine market surveillance. This move comes as a proactive measure to safeguard public health, following the detection of degradation in the medications, which were still within their expiry period.

The first product, Salbutamol Oral Solution BP 2mg/5ml (100ml), manufactured by Ronald Pharmaceuticals in India and distributed by Serenba Pharmaceuticals, has been found to change from a clear solution to a yellowish or orange color, with crystal formations. This medication, widely used for respiratory conditions such as asthma, was produced in June 2022 with an expiry date of May 2025 (Batch No. 220656). However, the visible changes indicate a potential degradation of the solution, raising concerns about its efficacy and safety.

The second product, Plasmodial 80+480 (Artemether 80mg & Lumefantrine 480mg tablets), is a key antimalarial treatment manufactured by Alchemy Medicine in India and distributed by EMJ Pharmacy. The MCA’s surveillance revealed the development of dark spots on the tablets, possibly due to mold growth. This batch (No. ALTF-2206), produced in May 2022 and set to expire in April 2025, has been pulled from the market as a precautionary measure. Mold contamination can compromise the medication’s potency and present additional health risks to patients, especially in a country where malaria remains a major public health concern.

The MCA has advised the public to immediately return any of these products to the pharmaceutical outlets or health facilities where they were purchased. In addition, all pharmaceutical outlets and health facilities have been instructed to surrender the affected batches to the MCA for proper disposal.

This recall highlights the importance of rigorous quality control in safeguarding public health, particularly in a region that relies heavily on imported pharmaceuticals. It also echoes lingering concerns raised after The Gambia faced an unprecedented public health crisis in 2022 with the Acute Kidney Injury (AKI) scandal, which was linked to contaminated cough syrups imported from India. The tragic incident claimed the lives of over 70 children and drew international attention to the vulnerabilities in The Gambia’s drug regulation system.

The AKI scandal exposed serious gaps in the country’s pharmaceutical importation processes and highlighted the need for stricter monitoring of drug quality, especially for products sourced from abroad. The World Health Organization (WHO) launched an investigation, concluding that the toxic compounds found in the syrups were linked to faulty manufacturing practices. The Gambian government vowed to overhaul its drug regulatory framework, with the MCA playing a central role in ensuring better surveillance and control mechanisms.

This recent recall of substandard medications reinforces the need for continued vigilance in drug quality control, particularly as The Gambia continues to rely on international pharmaceutical imports. The MCA’s swift action, while commendable, underscores a broader issue—ensuring that only safe, effective, and high-quality medicines enter and circulate within the Gambian market.

As The Gambia continues to rebuild trust in its healthcare system following the 2022 crisis, this recall serves as a critical reminder of the ongoing need for stringent regulatory oversight to prevent further tragedies. The MCA’s efforts to protect public health are vital, but the public remains on high alert, demanding accountability and transparency in the pharmaceutical supply chain.

MCA’s Call to Action

The MCA urges the public and health professionals alike to remain vigilant and report any adverse reactions or quality issues with medicinal products to the agency promptly. The recall process is a crucial part of ensuring that substandard drugs are swiftly removed from circulation before they can cause harm.

The agency’s quick response reflects an ongoing commitment to improving drug safety in the country, but it also raises questions about the continued risks posed by imported medicines. As the country looks to strengthen its regulatory capacity, the lessons from both this recall and the devastating 2022 AKI crisis remain at the forefront of public health policy discussions in The Gambia.