News / National
MCAZ recalls 3 Remedica medicines over quality concerns
2 hrs ago |
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THE Medicines Control Authority of Zimbabwe (MCAZ) has ordered a Class II recall of three medicines manufactured by Remedica Ltd of Cyprus after the manufacturer identified confirmed out-of-specification results during ongoing stability testing.
The recall affects specified batches of Nifedipine 10mg tablets, Levodopa/Carbidopa 100mg/25mg tablets and Levodopa/Carbidopa 250mg/25mg tablets.
In a circular dated September 7, 2026, MCAZ director-general Richard Tendayi Rukwata said the recall had been extended to the retail level following confirmation of the quality concerns.
"The Authority hereby institutes a Class II recall up to retail level of the above batches," Rukwata said.
The affected Nifedipine 10mg tablets, batches H2033 and 117367, were found to have dissolution-profile results outside specifications, mainly affecting the early stages of dissolution, although the remaining stages were within specification.
For Levodopa/Carbidopa 100mg/25mg tablets, batches 97261, 102600, 102603 and 107232 were affected by changes in appearance, with the tablets changing from yellow to dark yellow or brownish at the end of their shelf life.
The recall also covers Levodopa/Carbidopa 250mg/25mg tablets, batches 99671, 102751 and 102752.
According to MCAZ, the tablets changed in appearance from blue to yellowish-green, while recurring out-of-specification results associated with a decrease in the Carbidopa assay were also identified.
MCAZ has directed all licensed pharmaceutical wholesalers, pharmacies, public and private clinics and hospitals to immediately stop distributing and selling the affected batches.
Healthcare facilities and other suppliers have also been instructed to return any affected stock in their possession to their suppliers.
Members of the public who have any of the affected medicines have been advised to stop using them and return them to the pharmacy or health facility where they obtained them.
"The Authority shall continue to monitor the situation and will communicate further guidance as necessary," the circular said.
The recall affects specified batches of Nifedipine 10mg tablets, Levodopa/Carbidopa 100mg/25mg tablets and Levodopa/Carbidopa 250mg/25mg tablets.
In a circular dated September 7, 2026, MCAZ director-general Richard Tendayi Rukwata said the recall had been extended to the retail level following confirmation of the quality concerns.
"The Authority hereby institutes a Class II recall up to retail level of the above batches," Rukwata said.
The affected Nifedipine 10mg tablets, batches H2033 and 117367, were found to have dissolution-profile results outside specifications, mainly affecting the early stages of dissolution, although the remaining stages were within specification.
For Levodopa/Carbidopa 100mg/25mg tablets, batches 97261, 102600, 102603 and 107232 were affected by changes in appearance, with the tablets changing from yellow to dark yellow or brownish at the end of their shelf life.
The recall also covers Levodopa/Carbidopa 250mg/25mg tablets, batches 99671, 102751 and 102752.
According to MCAZ, the tablets changed in appearance from blue to yellowish-green, while recurring out-of-specification results associated with a decrease in the Carbidopa assay were also identified.
MCAZ has directed all licensed pharmaceutical wholesalers, pharmacies, public and private clinics and hospitals to immediately stop distributing and selling the affected batches.
Healthcare facilities and other suppliers have also been instructed to return any affected stock in their possession to their suppliers.
Members of the public who have any of the affected medicines have been advised to stop using them and return them to the pharmacy or health facility where they obtained them.
"The Authority shall continue to monitor the situation and will communicate further guidance as necessary," the circular said.
Source - Newsday
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