NAFDAC destroys 828 cartons of contaminated Bioflex infusions over failed sterility tests Nexovant

The National Agency for Food and Drug Administration and Control (NAFDAC) said it has destroyed 828 cartons of Bioflex infusions over failed sterility tests.

The infusions, supplied by Biomedical Company Limited, Ilorin, were flagged following a consumer complaint from Ahmadu Bello University Teaching Hospital (ABUTH), Shika.

The complaint highlighted the presence of suspended particles in the infusions, prompting an investigation by the North-West Zonal Office (NWZ) of the Agency.

Laboratory findings and regulatory measures

NAFDAC said laboratory analysis revealed that the products failed sterility tests, posing potential health risks.

In a statement on its X handle on Tuesday, NAFDAC stated, “With the approval of the @DGatNAFDAC, the NWZ oversaw the forfeiture and subsequent destruction of the contaminated infusions.

“The products were removed from their secondary packaging, crushed, and buried, while the cartons were burnt to ensure complete disposal.”

NAFDAC said it remained committed to ensuring the safety and quality of medical products in Nigeria and urged the public to promptly report any suspicious products for swift regulatory action.

Previous regulatory interventions

Earlier in the year, NAFDAC flagged the sale of an unregistered brand of Ceftriaxone Sodium Injection, marketed as ZACEF-TZ Injection, in Nigeria. This discovery followed an investigation by the Post-Marketing Surveillance (PMS) unit in the Federal Capital Territory (FCT), Abuja, after receiving a consumer complaint.

Ceftriaxone and Tazobactam Injection is a combination antibiotic used for treating bacterial infections. However, NAFDAC raised concerns about the illegal sale of substandard and falsified medicines, warning that such practices pose serious health risks.

“The illegal marketing of substandard and falsified medicines poses a risk to the health of people, since by not complying with the regulatory provisions, the safety, quality, and efficacy of the products are not guaranteed,” NAFDAC stated.

Falsified registration and packaging concerns

The agency disclosed that the NAFDAC Registration Number (NRN) A-46344 displayed on ZACEF-TZ Injection is falsified and non-existent in its database.

Additionally, the product lacks manufacturer details and a patient information leaflet in its packaging. NAFDAC noted its similarity to a registered drug, EXACEF-TZ Injection, which contains the same active ingredients, Ceftriaxone Sodium and Tazobactam Sodium.

More insights

Contaminated infusions can have severe and potentially life-threatening effects, particularly for patients who are already vulnerable.

Patients may develop infections at the infusion site, such as phlebitis or cellulitis.
Contaminants like toxins or chemical residues can trigger severe reactions, including organ damage or failure.
Contaminated infusions can worsen existing health conditions, delay healing, or prolong hospital stays, increasing the burden on healthcare systems.

Preventing contamination through rigorous quality control and adherence to sterility standards is crucial to ensuring patient safety.

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