The Pharmacy and Poisons Board (PPB) has flagged an unregistered anti-cancer drug currently in circulation in the Kenyan market.
In a statement on Wednesday, December 11, 2024, the board stated that they discovered that the Floracil 1000 (Fluorouracil 1000mg/2ml) Injection was in the market despite failing to undergo their approval.
“During routine post-market surveillance (PMS) activities, the Board identified an unregistered and substandard product, Floracil 1000 (Fluorouracil 1000mg/2ml) Injection, manufactured by Bruck Pharma PVT LTD, India,” the board said.
“In light of this, the Board strongly cautions the public and healthcare professionals against the trade, distribution, wholesale, retail, issuance, dispensing, use, or administration to patients of this product.“
The pharmacy board also warned those involved in the sale and distribution of the drug, noting that appropriate action would be taken against them.
“Further, in collaboration with Government Investigative Agencies, the Board will take legal and regulatory action against any individuals involved in placing this unregistered product in the market, in violation of the Pharmacy and Poisons Act (CAP 244),” the board’s statement reads.
Another cancer drug
This comes just a week after the board removed another cancer drug from circulation, indicating that it had yet to comply with the Kenyan standards.
“The Pharmacy and Poisons Board orders the quarantine of Flurasted 500 (5-Fluorouracil) Injection Batch no. HHP24017 manufactured by Halsted Pharma Private Limited, India. The quarantine order is being issued due to a market complaint on the appearance parameter of the content. Flurasted 500 (5-Fluorouracil Injection used in the management of cancer,” the board said.
Adding; “In light of this, the Board advises all pharmaceutical outlets, healthcare facilities, healthcare professionals, and members of the public to immediately quarantine the product batch and stop the further distribution, sale, issuance, or use of the affected batch.”
The board encourages the public to report any suspected cases of substandard medicines or adverse drug reactions to the nearest healthcare facility or the Pharmacy and Poisons Board
Painkiller drug flagged
Similarly, the board also suspended the distribution and sale of an oral suspension used as a painkiller on Wednesday, December 11, 2024.
“The Pharmacy and Poisons Board (“the Board”) informs the public of a Quarantine Order issued for Mefnac Oral Suspension (Mefenamic Acid 50 Mg/5 MI) Manufactured by Efroze Chemical Industries P Pvt Ltd, Pakistan,” the board said.
Adding: “This action has been taken due to suspected contamination with Diethylene Glycol (DEG)/Ethylene Glycol (EG) at levels above the acceptable limits. In light of this, the Board advises all pharmaceutical outlets, healthcare and members of the public to immediately facilities, healthcare professionals, and members of the public to immediately quarantine the product and stop the further distribution, sale, issuance, or use until further communication from the Board.”
