The National Agency for Food and Drug Administration and Control has alerted the public regarding an unregistered product, Gold Vision Oxytocin injection 10IU, which displays a fake NAFDAC registration number: A4-9566.
According to NAFDAC, the product is purportedly manufactured by Anhui Hongye Pharmaceutical Co., Ltd., located at Fengyang East Road, Bengbu, Anhui Province, China, and marketed by Gold Vision Medicals, No.4 Range Avenue, Independence Layout, Enugu, Nigeria.
“The product was discovered during a Risk-Based sampling survey activity conducted by officers of the Post Marketing Surveillance (PMS) directorate of NAFDAC. Further investigation revealed that three (3) falsified products, namely A-tocin injection, Extocin Injection, and Claxitodin injection, were discovered during the 2023 RBPMS sampling.
“The products were said to have been manufactured by the same manufacturer, and all the products bear the same falsified NAFDAC Reg. No. A4-9566. It is essential to highlight that these products identified in this alert are confirmed as falsified because they are not present in the NAFDAC-registered products database,” the agency said in a statement.
NAFDAC explained that oxytocin is a naturally occurring hormone and neuropeptide, also available as a pharmaceutical drug, primarily used to induce or strengthen labor, control postpartum bleeding, and support lactation.
“It binds to oxytocin receptors on the smooth muscle of the uterus, activating a G-protein-coupled receptor pathway. This leads to increased intracellular calcium levels, causing uterine contractions,” the regulatory body noted.
The agency warned that using unregistered or falsified oxytocin injections poses serious health risks to both mothers and newborns, emphasising that the products may contain incorrect doses, no active ingredient, or harmful contaminants, leading to ineffective uterine contractions, postpartum hemorrhage (PPH), and even maternal death.
It added that poor-quality oxytocin may also delay or fail to stop bleeding after childbirth, increasing the need for emergency interventions like blood transfusions or surgery.
Details of the Falsified Products
Product Name: Gold Vision Oxytocin injection 10IU (OXYTOCIN INJECTION), A-tocin injection, Extocin Injection, and Claxitodin injection.
Fake NAFDAC Reg. No: A4-9566.
Product Manufacturer: Anhui Hongye Pharmaceutical Co., Ltd., Fengyang East Road, Bengbu, Anhui Province, China.
Marketed by: Gold Vision Medicals, No.4 Range Avenue, Independence Layout, Enugu, Nigeria.
NAFDAC ordered all its zonal directors and state coordinators to conduct surveillance and retrieve any of the falsified products if found within their zones and states in Nigeria.
The regulatory body advised importers, distributors, retailers, healthcare professionals, and consumers to remain vigilant within the supply chain to avoid the importation, distribution, sale, and use of unregistered or falsified oxytocin injection.
It advised that all medicinal products and medical devices must be obtained from authorised or licensed suppliers, stressing that the products’ authenticity and physical condition should be carefully checked.
NAFDAC also urged healthcare professionals and consumers to report any suspicious sale of substandard and falsified medicines or medical devices to its nearest office, through 0800-162-3322, or via email: sf.alert@nafdac.gov.ng.
The agency further encouraged healthcare professionals and patients to report adverse events or side effects related to the use of medicinal products or devices to its nearest office.
The report can also be done through the use of the E-reporting platforms available on 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.
