INTERNATIONAL Drug Company (IDC) Limited says they have complied with a Zambia Medicine Regulatory Authority’s (ZAMRA) directive by recalling aspirin which had a foul smell.
In a letter dated, December 7, 2020, ZAMRA director general Bernice Mwale wrote to the IDC director directing them to initiate an urgent recall of the affected batch from circulation within 14 days.
“RE: RECALL OF ASPIRIN 75MG TABLETS USP BATCH NO ET- 905 MANUFACTURED BY WINTECH PHARMACEUTICALS LIMITED INDIA. Reference is made to the above subject matter; The authority has received a medical product quality problem report relating to aspirin 75mg tablets supplied by your company. On inspection, the product has been found non-compliant with respect to appearance and organoleptic tests conducted. The product has been found to have crystals on the tablet coating that has a foul smell and tablets are breaking easily. Product details, product name: aspirin tablets USP 75mg batch number, ET 905 marketing authorisation number; not stated. Manufacturing date 07/2019. Expiry date 06/2022; Manufacturer Wintech Pharmaceuticals Limited India (for Bhor International, India),” stated Mwale.
“Therefore, you are directed to initiate an urgent recall of the affected batch from circulation within 14 days from the day of receipt of this letter; use of press media with wide coverage is highly commended. You are further required to submit to the Authority a detailed report of the recall process, which should include the quantity of the product imported and the quantity collected from various health facilities and pharmaceuticals outlets. You are also instructed to notify the manufacturer of the product to conduct an investigation and provide feedback on the product defect and corrective and preventive actions put in place to avoid occurrence of such a defect in future. The Authority wishes to inform you that it will closely monitor the recall to ensure that the product is completely removed from circulation in the interest of public health. Should you need further clarification, please do not hesitate to contact the secretariat.”
In an interview, IDC representative, only identified as Sajid, said the company had started the process of recalling.
“We have started the process of recalling. In Lusaka, we only delivered to Medical Stores. Immediately we got the letter, we went to Medical Stores and gave them the details. So, the recall is done. On that one [quantities] I need to check in the system when I reach the office,” said Sajid.
And ZAMRA public relations manager Ludovic Mwape confirmed that IDC had complied.
“I think the distributor, IDC, is doing everything to ensure that the products are recalled. I understand they have informed all the districts that they had supplied to, to quarantine the product. We are following the matter since it is an instruction that we gave them so we have to see that they follow that. But they are yet to publish that. They have complied. Just to try to contact them and find out,” said Mwape in an interview.
But former Pharmaceutical Society of Zambia (PSZ) Jerome Kanyika said that he had not seen any letter of recall from the supplier.
“We have not seen any letter of recall of the same supplier. Let the supplier write to members of the public and recall their medication and put photos of their medication so that the people, who may still have that aspirin may stop using them. And now, if these matters of recall are coming up, we need to find a way of compensating people that may consume such kinds of products. This is a product that a person uses when they have a heart problem and we know how delicate the heart is, if anything goes wrong, you are gone,” cautioned Kanyika.