Nigerian authorities has issued a public alert regarding a voluntary recall of Zovirax IV Infusion 250mg, following a safety notification from the Department of Health in Hong Kong.
The move comes after a complaint raised concerns about the presence of glass-like particles in a batch of the antiviral drug manufactured by GlaxoSmithKline (GSK).
This was made know through National Agency for Food and Drug Administration and Control (NAFDAC) X page on Tuesday.
According to the agency report, the affected batch (RN3T), though not listed in the NAFDAC database, was produced using the same intermediate materials as a previously flagged batch (RP8K) in Taiwan.
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GSK has now initiated a precautionary recall of the potentially compromised products.
Zovirax IV contains Acyclovir and is used to treat viral infections such as genital herpes, shingles, chickenpox, encephalitis, and other conditions caused by the herpes simplex and varicella-zoster viruses.
It is often administered to newborns, immunocompromised patients, and individuals with severe initial outbreaks of genital herpes.
NAFDAC warns that the presence of particulate matter in intravenous infusions can pose serious health threats.
These include phlebitis (vein inflammation), thrombophlebitis (blood clots in veins), granuloma formation, and in severe cases, pulmonary complications or even death.
NAFDAC is urging importers, healthcare providers, distributors, and consumers to exercise extreme caution and vigilance. While the affected batch has not been confirmed in Nigeria, stakeholders are advised to:
Avoid the importation, distribution, sale, or administration of the recalled product, ensure all medicines are sourced from authorized or licensed suppliers, and inspect products for authenticity and physical integrity.
NAFDAC noted that any suspected cases of substandard or falsified medicines should be reported to NAFDAC via their toll-free line at 0800-162-3322 or email: sf.alert@nafdac.gov.ng.
Also, the agency noted that adverse reactions or side effects related to the use of Zovirax IV should also be reported through the nearest NAFDAC office, E-reporting platform on the NAFDAC website (www.nafdac.gov.ng)
Othe channels include, the Med-Safety App, available on Android and iOS and provided email address: pharmacovigilance@nafdac.gov.ng.
NAFDAC has confirmed that this safety notice will be shared with the WHO Global Surveillance and Monitoring System (GSMS) to ensure broader international awareness and monitoring.
