The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying the public that GlaxoSmithKline (GSK) Limited has voluntarily recalled one lot of Zovirax IV Infusion 250mg RN3T in Hong Kong due to potential quality defects.
The Department of Health (DH) Hong Kong received notification from GSK that its branch in Taiwan is initiating a voluntary recall following a complaint reporting glass-like particles in a batch (RP8K) of the product Zovirax IV Infusion 250mg. Although this batch was not supplied to Hong Kong, upon investigation, the batch (RN3T) in Hong Kong is considered to have the same potential quality issue, as both batches were manufactured using the same batch of intermediates. As a precautionary measure, GSK is voluntarily recalling the affected batches of product from the market.
Zovirax IV Infusion 250mg contains Acyclovir (Acyclovir) as the main ingredient. It is an antiviral agent used in the treatment of viral infections such as genital herpes, shingles, chickenpox, Encephalitis, and other related conditions caused by the herpes zoster virus, varicella-zoster. It is indicated for the treatment of Herpes simplex infections in newborns, immunocompromised patients, and severe initial genital herpes in the non-immunocompromised.
Risk Statement: Particulate matter contamination in infusions can lead to complications like phlebitis, thrombophlebitis, and granuloma formation. In severe cases, it may also result in pulmonary dysfunction and death.
Product details
The details of the products are as follows.
Product Name: Zovirax IV Infusion 250mg
Product Manufacturer: GlaxoSmithKline (GSK) Limited
Batch Number: RN3T
Product Image
Although the product is not listed in the NAFDAC database, NAFDAC urges importers, distributors, retailers, healthcare providers, and patients to exercise caution and vigilance throughout the supply chain. This is essential to prevent the importation, distribution, sale, administration, or use of recalled products. All medical products must be obtained 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 substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 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 the affected product 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!!!
