The Ministry of Health, through the Pharmacy and Poisons Board (PPB), has urgently recalled a cancer medication, Flurasted 500 (5-Fluorouracil) Injection, due to concerns regarding its physical appearance.
The recall pertains specifically to batch number HHP24017, manufactured by Halsted Pharma Private Limited in India. Healthcare providers and pharmacies are directed to halt the use and distribution of this batch effective Thursday, December 5. This decisive action follows multiple complaints indicating issues with the medication’s quality.
“The Pharmacy and Poisons Board (“the Board”) orders the quarantine of Flurasted 500 (5-Fluorouracil) Injection Batch No. HHP24017 Manufactured by Halsted Pharma Private Limited, India,” the Pharmacy and Poisons Board announced in a statement.
The PPB highlights the visual integrity of the drug as the primary concern, emphasizing the importance of maintaining rigorous quality control in pharmaceutical manufacturing. Flurasted 500 is a vital component in chemotherapy regimens for various cancers, including colon, breast, and stomach cancer, effectively disrupting the growth of cancerous cells.
In light of the situation, healthcare practitioners have been instructed to cease the administration of Flurasted 500 from the affected batch immediately. Furthermore, all pharmaceutical outlets, including healthcare facilities and professionals, are required to quarantine this batch to prevent any further use or distribution. The public is also encouraged to report any suspected substandard medications to the nearest health facility for immediate investigation.
”The quarantine order is being issued due to a market complaint on the appearance parameter of the content. Flurasted 500 (5-Fluorouracil) Injection is used in the management of cancer,’’ the notice added.
The recall of Flurasted 500 comes on the heels of a previous alert from the PPB, issued on November 22, regarding two batches of Efinox nasal drops that were withdrawn due to a labelling and packaging mix-up, which resulted in variations in the drugs’ potency. The affected Efinox batches, identified as Efinox 1% w/v Batch No. 82979 and Efinox 0.5% w/v Batch No. 82978, were categorized as unsafe for use due to these discrepancies.
