ZAMBIA Medicines Regulatory Authority (ZAMRA) director general Bernice Mwale has ordered HoneyBee Pharmacy to recall all batches of Paracetamol tablets which it supplied to the Ministry of Health within 14 days, saying it does not meet some specifications.
And Mwale has asked HoneyBee to further submit to the authority a detailed report of the recall process, which should include the quantity of drugs imported and those supplied to health facilities.
“The authority wishes to notify you that samples of paracetamol tablets BP 500mg batch numbers PPYP-03 and PPYP-04 manufactured by Prashi Pahrma Pvt Limited, India, and supplied by your company were analysed at the National Drug Quality Control Laboratory and were found out of specification with respect to appearance (refer to the Certificate of Analysis numbers ZAMRA/0017/20/0020-1 and ZAMRA/0017/20/0021-1 attached). In view of the foregoing, you are directed to initiate an urgent recall of ALL batches of paracetamol tablets BP 500mg from circulation within 14 days from the day of receipt of this letter. Use of press media with wide coverage is highly recommended,” Mwale stated.
Mwale further directed HoneyBee to notify the manufacturer of the drugs, who should, in-turn, provide feedback on the product defects as well as preventive measures.
“You are further required to submit to the authority a detailed report of the recall process, which should include the quantity of the products imported and the quantity collected from the various health facilities. You are also instructed to notify the manufacturer of the product to investigate and provide feedback on the product defect and corrective and preventive actions put in place to avoid occurrence of such a defect in the future. The authority wishes to inform you that it will closely monitor the recall to ensure that the products are completely removed from circulation in the interest of public health. Should you need further clarification, please do not hesitate to contact the secretariat,” stated Mwale.
Last week, News Diggers! published an article about the controversial US $17 million Health Centre Kits awarded to HoneyBee Pharmacy, which culminated into a supply of damaged and toxic drugs to the Ministry of Health.
But HoneyBee Pharmacy manager Zackir Motala argued that the discolouration on the drugs was the fault of the manufacturer, who he said had been contacted to recall the drug.