The National Agency for Food and Drug Administration and Control (NAFDAC) confirms the destruction of 828 cartons of Bioflex infusions due to failed sterility tests, which pose potential health risks.
The infusions, produced by Biomedical Company Limited in Ilorin, come under scrutiny following a consumer complaint from the Ahmadu Bello University Teaching Hospital (ABUTH), Shika. The complaint highlights the presence of suspended particles in the infusions, prompting an investigation by NAFDAC’s North-West Zonal Office (NWZ).
Laboratory Analysis and Disposal
NAFDAC’s laboratory analysis confirms that the infusions fail sterility tests, making them unsafe for use. Following this discovery, the agency oversees the forfeiture and destruction of the contaminated products.
In an official statement on Tuesday, NAFDAC explains, “With the approval of the Director General, the North-West Zonal Office coordinated the removal, crushing, and burial of the infusions, while their packaging was incinerated to ensure complete disposal.”
NAFDAC stresses its dedication to ensuring the safety and quality of medical products in Nigeria and urges the public to report any suspicious or substandard items for immediate action.
Earlier Regulatory Interventions
Earlier in the year, NAFDAC uncovers the illegal sale of an unregistered Ceftriaxone Sodium and Tazobactam Injection, marketed as ZACEF-TZ Injection. This discovery follows an investigation by its Post-Marketing Surveillance (PMS) team in Abuja, triggered by a consumer complaint.
The agency warns that the illegal distribution of unregistered and falsified medicines undermines public health, as these products do not meet the required safety, quality, and efficacy standards.
NAFDAC reveals that ZACEF-TZ Injection carries a fake registration number and lacks key packaging details, including manufacturer information and a patient information leaflet. The product closely resembles EXACEF-TZ Injection, a registered antibiotic with the same active ingredients.
Risks of Contaminated Medical Products
NAFDAC highlights the severe health risks associated with contaminated infusions, including:
- Infections: Patients may develop site infections like cellulitis and phlebitis.
- Toxic Reactions: Chemical contaminants can cause organ damage or failure.
- Delayed Recovery: Worsened conditions, prolonged healing, and extended hospital stays increase pressure on healthcare systems.
The agency underscores the importance of strict adherence to quality control and sterility standards in protecting patient health and ensuring the safety of medical products across Nigeria.
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