The Food and Drugs Authority (FDA) of Ghana has issued a safety alert following notifications from the WHO Rapid Alert System for Falsified and Substandard Medical Products.
Certain batches of PARADENK SUPPOSITORIES (Paracetamol) with defective packaging materials have been imported and distributed in the country.
Issue with the Product
Quality control checks conducted after release identified that the packaging of the affected batches is compromised. The blisters lack proper tightness, which may impact the product’s safety and efficacy over its shelf life.
PARADENK SUPPOSITORIES (Paracetamol) is commonly used to relieve mild to moderate pain in children and for patients who have difficulty swallowing tablets. While the defective packaging does not pose an immediate health risk, the medication’s effectiveness could be affected.
The marketing authorization holder, Denk Pharma GmbH & Co. KG, Munich, Germany, has initiated a voluntary recall, and the FDA is working closely with Denk Pharma’s local agent in Ghana to remove the affected batches from the distribution chain.
Guidance for the Public and Healthcare Professionals
Do not panic. The affected batches do not pose immediate health risks.
Stop using any PARADENK SUPPOSITORIES (Paracetamol) from the affected batches.
Return remaining stock to the nearest FDA office.
For inquiries, contact the FDA Safety Monitoring Department at 0244 310 297.
The FDA remains committed to safeguarding public health and urges healthcare professionals and the public to assist in removing the affected batches from circulation.
