The National Agency for Food and Drugs Administration and Control (NAFDAC) informs the public of the illegal manufacturing, distribution, and marketing of a substandard and falsified Paediatric Asian Ampicillin /Cloxacillin oral suspension in Kano State.
About 2,460 bottles of this product were discovered in six shops following painstaking intelligence and surveillance by Regulatory Officers in Kano State.
The Substandard and falsified product has a fake NAFDAC Registration Number (NRN): A4-8255, this is the registration number of another NAFDAC registered product Zarcef-S 1500, a brand of Ceftriaxone Sodium 1g and Sulbactam 500mg injection registered by Shrezar Healthcare Nigeria Limited.
AMPICILLIN+CLOXACILLIN is composed of two antibiotics, namely: ampicillin and cloxacillin, used to treat bacterial infections of the ear, nose, throat, bones, lungs, and post-operative wound infections. Also, it is used to treat urinary tract infections, meningitis, gonorrhoea, and infections of the stomach or intestine.
Risk Statement
The illegal marketing of medicines or counterfeit medicines poses a great risk to the health of people, by not complying with the regulatory provisions, the safety, quality, and efficacy of the products are not guaranteed.
Product details
The details of the product are as follows.
Product Name: Asian Ampicillin /Cloxacillin oral suspension (125MG/125MG in 5MLs)
Batch Number: 001
Manufacturing date: 03/2024
Expiry date: 02/2027
Stated NRN: A4-8255
Name and Address of Manufacturer: Asian Pharmaceutical Ltd. 18/20 Burma Road, P.O. Box 1822, Apapa, Lagos, Nigeria.
Please note that the above NRN (NAFDAC Registration Number) is falsified.
Product picture
Other falsified Asian products are 1. Ampicillin 125mg Suspension 2. Erythromycin 125mg Suspension 3. Amoxicillin 125mg suspension 4. Artil-Go (Artemeter and Lumefantrine) suspension.
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the falsified products within their zones and states.
Importers, distributors, retailers, healthcare professionals, and caregivers are advised to exercise caution and vigilance within the supply chain to avoid the product’s importation, distribution, sale, and use. All medical products must be sourced from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC – 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!
