NAFDAC Issues Warning on Unregistered Antibiotic: ZACEF-TZ Injection

The National Agency for Food and Drugs Administration and Control (NAFDAC) has raised concerns over the sale of an unregistered Ceftriaxone Sodium Injection brand known as ZACEF-TZ Injection, prompting a public notice to safeguard public health.

The revelation follows an investigation initiated by the post-marketing surveillance (PMS) unit of the Agency in FCT, Abuja, triggered by a consumer complaint. The probe uncovered the distribution of the unregistered product within the FCT, leading to swift action to remove it from circulation in the area.

NAFDAC has issued directives to all zonal directors and state coordinators to conduct surveillance and eliminate the unregistered product from their respective zones and states.

Product Details

Ceftriaxone & Tazobactam Injection: A combination antibiotic commonly used for treating various bacterial infections.

Health Risks and Identifying Features

Unauthorized marketing of substandard and falsified medicines poses significant health risks, compromising safety, quality, and efficacy standards.
The purported NAFDAC Registration Number A-46344 displayed on the product is falsified and does not exist in the NAFDAC database.
The product lacks manufacturer details and does not include a patient information leaflet in the secondary pack.
The product shares a similar name (sound-alike) with a registered drug product, EXACEF-TZ Injection (Ceftriaxone Sodium + Tazobactam Sodium), containing the same active ingredient combination.

NAFDAC's Cautionary Measures

NAFDAC urges importers, distributors, retailers, healthcare professionals, and caregivers to exercise utmost caution and vigilance within the supply chain to prevent the importation, distribution, sale, and use of substandard and falsified products.

It is emphasized that all medical products must be sourced from authorized and licensed suppliers, with their authenticity and physical condition thoroughly verified.

Healthcare professionals and consumers are encouraged to report any suspicions of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, via the NAFDAC hotline or through email.

Adverse events or side effects related to the use of medicinal products or devices should be reported promptly to the nearest NAFDAC office or through the various reporting platforms available on the NAFDAC website and Med-safety application.

Conclusion

NAFDAC's vigilance and prompt action underscore the importance of maintaining stringent standards in the pharmaceutical supply chain to ensure the safety and well-being of consumers.