The Pharmacy and Poisons Board (PPB) has ordered a mandatory nationwide recall of the pain relief medication Tamedol oral solution after discovering quality issues with several batches of the product, the regulatory agency announced Tuesday.
The PPB said its investigation found numerous batches of the paracetamol-based medication manufactured by Biopharma LTD failed to meet required quality standards.
“In response to these concerns, the PPB upon investigations, indeed confirmed that the product FAILED to meet the prescribed market authorization requirements and has initiated mandatory recall of the product by the manufacturer,” the agency said in a statement.
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PPB Chief Executive Officer Dr. F.M. Siyoi said the recall aims “to guarantee that medicines supplied to the Kenyan market adhere to the requisite standards of quality, safety and efficacy.”
The agency advised all pharmacies, healthcare facilities, medical professionals and consumers to immediately quarantine any remaining stock of the recalled product and return it to suppliers or healthcare facilities.
Members of the public who have questions or concerns about the recall can contact the PPB through its website, mobile app, email or a dedicated telephone line, the agency said.
Siyoi encouraged consumers to remain alert about medication safety. “We encourage the public to remain vigilant at all times and promptly report any suspected cases of sub-standard medicines or adverse drug reactions,” he said.
The PPB regulates the manufacture, importation, exportation, distribution and use of pharmaceutical products in Kenya.