The Medicines Control Authority of Zimbabwe has ordered the recall of specified batches of Nifedipine 10mg and Levodopa/Carbidopa tablets after the products failed quality tests.
The Class II recall, which extends to retail level, affects medicines manufactured by Remedica Ltd of Limassol, Cyprus.
According to MCAZ, the recall follows confirmed “Out-Of-Specification results” identified by the manufacturer during ongoing stability testing of the affected products.
The affected Nifedipine 10mg tablets are batches 112033 and 117367, which were found to have dissolution-profile problems, mainly during the early stages of dissolution.
The Authority also recalled Levodopa/Carbidopa 100mg/25mg tablets from batches 97261, 102600, 102603 and 107232 after the tablets changed in appearance from yellow to dark yellow or brownish towards the end of their shelf life.
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Levodopa/Carbidopa 250mg/25mg tablets from batches 99671, 102751 and 102752 were also affected, with the tablets changing from blue to yellowish green and recurring OOS results linked to a decrease in Carbidopa assay.
MCAZ has directed licensed pharmaceutical wholesalers, pharmacies, as well as public and private clinics and hospitals to “immediately cease further distribution and sale” of the affected batches.
They have also been ordered to return any remaining stock to their suppliers.
Members of the public who have any of the affected medicines have been advised to “stop using them and to return them to the pharmacy or health facility from which they were obtained.”
The authority said it will continue monitoring the situation and issue further guidance where necessary.
MCAZ is Zimbabwe’s medicines regulatory authority and is responsible for ensuring that medicines, allied substances and medical devices available in the country are safe, effective and of good quality.
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