The Pharmacy and Poisons Board (PPB) has issued a recall for specific batches of the Tamedol painkiller due to alleged quality issues.
In an official statement, the PPB called on the public to return certain batches of paracetamol oral solution sold under the brand name Tamedol, citing non-compliance with market requirements.
Why Tamedol was Recalled
PPB CEO Fred Siyoi explained that the decision to recall the product came after the authority received numerous complaints regarding the quality of several batches of Tamedol oral solution (120mg/5ml, 60mls), manufactured by Biopharma Ltd.
“PPB upon investigations indeed confirmed that the product failed to meet the prescribed market authorization requirements and has initiated the mandatory recall of the product by the manufacturer in line with section 3A(i) of the Pharmacy and Poisons Act (Cap.244),” Siyoi said.
Tamedol is a commonly used painkiller for various conditions, including headaches, colds, backaches, period pain, and muscle pain.
Upon receiving the complaints, the PPB conducted investigations into the reported issues and confirmed that the product failed to meet the prescribed market authorization requirements.
Consequently, the mandatory recall of the product was initiated by the manufacturer, in accordance with section 3A(i) of the Pharmacy and Poisons Act (Cap.244).
As a precautionary measure, the PPB advised all pharmaceutical outlets, healthcare facilities, healthcare professionals, and the public to take immediate action.
Individuals in possession of the specified batch are required to either quarantine the product, meaning they should cease further distribution, sale, or use of Tamedol oral solution, or return it to specified points.
The PPB urged the public to remain vigilant and promptly report any suspected cases of substandard medicines or adverse drug reactions to the nearest healthcare facility or the PPB.
The authority emphasized its commitment to ensuring that medicines supplied to the Kenyan market adhere to the required standards of quality, safety, and efficacy.