The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert regarding the voluntary recall of a batch of Zovirax IV Infusion 250mg by pharmaceutical giant GlaxoSmithKline (GSK) Limited due to potential quality defects.
In a statement titled Public Alert No. 09/2025, NAFDAC said the recall was initiated after the Department of Health (DH) in Hong Kong received a complaint about the presence of “glass-like particles” in a batch of the intravenous antiviral drug.
According to NAFDAC, “GSK Taiwan initiated the voluntary recall following a quality complaint involving batch RP8K of Zovirax IV Infusion 250mg. Although this batch was not supplied to Hong Kong, another batch, RN3T, which shares the same batch of intermediates, was distributed in the region and is being recalled as a precaution.”
Zovirax IV Infusion 250mg contains Acyclovir, a potent antiviral medication used in the treatment of severe viral infections including genital herpes, shingles, chickenpox, encephalitis, and herpes simplex infections in newborns and immunocompromised patients.
NAFDAC warns that the presence of particulate matter in intravenous infusions poses serious health risks. “Contamination with foreign particles can lead to complications such as phlebitis, thrombophlebitis, granuloma formation, and in severe cases, pulmonary dysfunction and death,” the agency stated.
Although the recalled batch is not listed in NAFDAC’s product database, the agency is urging vigilance across Nigeria’s pharmaceutical supply chain. “Importers, distributors, retailers, healthcare providers, and patients must exercise caution to avoid the importation, sale, or use of the affected product,” NAFDAC advised.
The agency emphasized the importance of purchasing medical products only from authorized suppliers and urged the public to report any suspicion of substandard or falsified medicines. Reports can be made via the toll-free number 0800-162-3322 or by email at sf.alert@nafdac.gov.ng.
NAFDAC also called on healthcare professionals and patients to report any adverse effects linked to the use of Zovirax IV Infusion through its e-reporting platform on the agency’s website, the Med-Safety app (available on Android and iOS), or via email at pharmacovigilance@nafdac.gov.ng.
The recall alert, NAFDAC noted, will also be forwarded to the World Health Organization’s Global Surveillance and Monitoring System (GSMS).
For now, the agency says it will continue to monitor the situation and take necessary regulatory actions to protect public health.
