• ZAMRA has issued nationwide withdraw of White Rose Absorbent Cotton Wool Hospital Grade.
• The product is used in sterile surgical procedures in various health facilities.
• The product poses has potential to introduce infections on wounds or surgical sites.
Zambia Medicines Regulatory Authority (ZAMRA) has issued an urgent nationwide withdraw of White Rose Absorbent Cotton Wool Hospital Grade.
“The Zambia Medicines Regulatory Authority is withdrawing ALL batches of White Rose Absorbent Cotton Wool Hospital Grade to the consumer level,” Authority’s Acting Director Genera has disclosed.
Makoma Siyanga explained the product was found non-compliant with respect to microbiological contamination and labelling requirements.
Mr. Siyanga said the product which claimed to be hospital grade manufactured by Ermine Enterprises Limited, Zambia, is used in sterile surgical procedures in various health facilities.
Mr. Siyanga noted that “the product poses a risk to public health as it has potential to introduce infections on wounds or surgical sites where the product is used.”
Mr. Siyanga explained that the product says it is packaged in a primary package made of a white and blue plastic, with one big white rose flower at the top of the package and other smaller ones spread across the entire blue portion of the package labelled ‘ For medical and sanitary use’ at the back of the package.
He narrated that the product was distributed nationwide in wholesale and retail outlets; including various health facilities.
He urged those in possession of the -mentioned product to return it to their supplier who should in turn notify ZAMRA.
“If you suffer any adverse drug reaction/event or suspect any other quality problem with the use of this product, you are advised to seek immediate medical advice and report the incident to the National Pharmacovigilance Unit al Zambia Medicines Regulatory Authority,” Mr Siyanga stated.
This was disclosed in an urgent notice to distributors, wholesalers, retailers, healthcare professionals and general public.
