Pharmacy Board recalls children’s fever drug over safety concerns

Board received complaints over the quality of Tamedol and a probe revealed the drug did not meet authorisation requirements.

Photo credit: Pool

The country’s drug regulator has recalled an oral medicine used as a pain reliever for children and for bringing down fever.

In a press statement updated on X (formerly Twitter), Pharmacy and Poisons Board (PPB) Chief Executive Officer Fred Siyoi said that the paracetamol oral solution called Tamedol should cease being distributed in the country with effect from Wednesday September 20, 2023.

Manufactured by Kenyan pharmaceutical company Biopharma Limited, the drug becomes the ninth drug to be recalled in 2023 alone.

Pharmacy and Poisons Board CEO Fred Siyoi.

Pharmacy and Poisons Board CEO Fred Siyoi.

Photo credit: File | Nation Media Group

Dr Siyoi said that the board initiated the revocation process after receiving a series of complaints from customers on the quality of a number of batches of Tamedol.

“In response to these concerns, the PPB upon investigations, indeed confirmed that the product failed to meet the prescribed market authorisation requirements and has initiated mandatory recall of the product,” he said.

The PPB has asked pharmacists to halt the sale of the drug and urged users who still have them to take the remaining batches to the nearest health facility.

The first drug to be taken off the shelves this year was Betamethasone Dipropionate, a cream used in the treatment of some skin conditions.

The PPB said the reason for stopping its distribution was because the drug had a potentially corrosive component that was used during the manufacturing of the products.

Other drugs were recalled in March, April, May and June.

Some of the reasons cited include discoloration of the drugs, signs of moulding, fragmented tablets, and crumbled capsules, among others.

Last year, the PPB rescinded 11 products from the market and the year that had the highest cancellation was 2019.

The PPB has asked members of the public to remain vigilant and report promptly should they suspect a subpar drug is in circulation.

Those who get adverse reactions are also advised to send their complaints to the board using the USSD code *271#, phone number 0795743049 or email address [email protected].