The Medicines Control Agency recalled two medications (Plasmodial tablets and Salbutamol Oral Solution) from the Gambian market on Saturday, October 4, 2024.

The Agency discovered two pharmaceuticals in circulation that, despite not having expired, have undergone pigment change as a result of degradation and are therefore considered substandard during its post-market surveillance.

Salbutamol Oral Solution BP 2 mg/5 ml, 100 ml, manufactured in June 2022 and imported and distributed by Serenba Pharmaceuticals Co Ltd in The Gambia. Batch number 220656 was produced in India by RONALD PHARMACEUTICALS PVT LTD and is set to expire in May 2025. The product was previously a clear solution; however, it is now yellowish or orange in color and contains crystals.

EMJ Pharmacy in The Gambia imports and sells PLASMODIAL 80+ 480 (Artemether 80 mg & Lumefantrine 480 mg, 6 Tablets/strip), which is manufactured in India by ALCHEMY MEDICINE PVT LTD. The product was manufactured in May 2022 and has a batch number of ALTF-2206; it is expected to expire in April 2025. The tablet’s pigment has been altered, and there are dark patches that may be the result of mold growth.

Despite the fact that these products are not expired, the Agency stated, “The public is advised against their use.” MCA has initiated the immediate recall of the afflicted batches of these two medicinal products.

Patients who possess these products are advised to return them to the pharmacies or medical facilities from which they were acquired.

The Agency has stated that the MCA Office or its inspectors who are conducting the recall in the field will receive these products from all Pharmaceutical Outlets and Health Facilities that possess them.

According to Mr. Essa Maranah, the executive director of the Medicine Control Agency, the two medications that are being recalled—Salbutamol Oral Solution BP 2 mg—did not experience any color changes during the importation process.

“All of these medications were in good condition and were not close to expiring.”According to him, these medications have undergone pigment changes as a consequence of degradation, despite the fact that they have not yet expired. Consequently, they are considered substandard.

The temperature at which they were stored was the most probable cause, as per ED Maranah.

We would like to notify the general public that these products have been recalled and should not be consumed. The reason for this is not that they failed the importation test; rather, it is due to the fact that they underwent a color change. According to the speaker, a change in color in pharmaceuticals typically signifies that they are no longer safe for use.