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The Pharmacy and Poisons Board (PPB) has issued an urgent public alert regarding a suspected substandard batch of Flurasted 500 (5-Fluorouracil) Injection, a drug commonly used in cancer treatment.
The affected batch, identified as Batch No. HHP24017 and manufactured by Halsted Pharma Private Limited in India, has been quarantined following complaints about its appearance parameter.
This move is part of the Board's continued commitment to safeguarding public health and ensuring the safety of medicines distributed and used in Kenya.
Concerns over substandard cancer drug
Flurasted 500 (5-Fluorouracil) Injection is widely used in the management of cancer and is a critical medication for many patients undergoing chemotherapy.
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The Board noted that the quarantine decision was made after a complaint was raised in the market regarding the product’s physical characteristics.
The quarantine order is being issued due to a market complaint on the appearance parameter of the content.
While it remains unclear whether the suspected irregularity has directly affected patients, the Board emphasised that any potential compromise in a drug’s quality could have severe implications, particularly for individuals already battling life-threatening illnesses such as cancer.
The Pharmacy and Poisons Board has issued strong instructions to all pharmaceutical outlets, healthcare facilities, and medical professionals to immediately stop the distribution, sale, or use of the affected batch.
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.
How to report suspected issues
To enhance its surveillance efforts, the Board is encouraging the public and healthcare providers to report any suspected cases of substandard drugs or adverse reactions.
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Multiple reporting channels have been established to ensure swift and efficient communication. Reports can be submitted through:
The PPB online portal: pv.pharmacyboardkenya.org
USSD code: *271#
Mobile application: mPvERS (available on Android and iOS)
Email: pv@ppb.go.ke or pms@ppb.go.ke
Telephone hotline: 0795743049
The Board assured the public of its commitment to addressing any complaints swiftly and ensuring the safety and efficacy of medicines distributed in Kenya.