Namibia Medicines Regulatory Council recalls Grand-Pa tablets and powders from Namibian Market

Eileen van der Schyff

The Ministry of Health and Social Services announced in a statement on 12 February 2021 the recall of Grand-Pa tablets and powders from the Namibian market. The Namibia Medicines Regulatory Council (NMRC) initiated the recall of this medicine manufactured by GlaxoSmithKline (GSK).

After the product failed stability studies at 30 degrees, the medicine is not fit to be stored under the climatic Zone IV of Namibia. It was decided that this medicine must not be imported or used within the country until further communication from the office of the Registrar of Medicines.
Stability studies prove the quality of a drug and serve as a basis for determining specifications and shelf-life information.
Long-term studies and investigations on the influence of storage time, temperature, humidity and light on a product determines temperature sensitive products. Follow-up studies can be done even after the approval of a drug to make adjustments to country of distribution, labeling or shelf-life.
The World Health Organisation (WHO) guideline describes the following climate zones:
· Zone I: “temperatures” 21°C/45% RH (relative humidity)
· Zone II: “subtropical” 25°C/60% RH
· Zone III: “hot/dry” 30°C/35% RH
· Zone IVa: “hot/humid” 30°C/65% RH
· Zone IVb: “hot/very humid” 30°C/75% RH

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