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The Zambia Medicines Regulatory Authority has directed Yash life Sciences Limited, Zambia to withdraw Vitamin B Complex Tablets from the market due to non-compliance.
Yash life Sciences Limited, Zambia has been given 14 days to withdraw the identified batch numbers for the medicine while warning its close monitoring of the recalling to ensure that the products are completely removed from circulation in the interest of public health.
In a notice to Yash life Sciences Limited, Zambia, ZMA acting Director General Makomani Siyanga, said the authority had received several Medical Product Quality Problem Reports relating to Vitamin B Complex Tablets.
Some of the reported batches are: 150422, 250422, 270422, 2804222, 460422 and 520422.
Siyanga said the products were reported by various health facilities to be discolouring.
Consequently, he said, Batch Number 250422 was analysed at the National Drug Quality Control Laboratory and found non-compliant with respect to Appearance test conducted.
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“Based on the reports and laboratory analysis performed, you are directed to withdraw all batches of Vitamin B Complex manufactured by your company from circulation within fourteen (14) days from the day of receipt of this letter.
“You are further required to submit, to the Authority, a detailed report of the withdraw process which should include the quantity of the affected product batches manufactured and supplied, as well as the quantities collected from the various health facilities the products were supplied to,” Siyanga said.
The authority also instructed to conduct thorough investigations 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.
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“Please note that until the above report is submitted and the Authority is convinced, you will be required to suspend manufacture of this product as the quality, safety and efficacy is not established.
“Furthermore, you are required to arrange for the safe disposal of the withdrawn product,” Siyanga said.
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