By Sukoluhle Ndlovu
The Medicines Control Authority of Zimbabwe (MCAZ) has recalled specified batches of three medicines after the products returned out-of-specification results during stability testing.
The recall affects Nifedipine 10mg tablets, Levodopa/Carbidopa 100mg/25mg tablets and Levodopa/Carbidopa 250mg/25mg tablets, all manufactured by Remedica Ltd of Limassol, Cyprus.
Nifedipine is used to treat high blood pressure and certain types of angina (chest pain), while Levodopa/Carbidopa is used to manage the symptoms of Parkinson’s disease, including slowness of movement, stiffness and tremors.
“The recall follows confirmed Out-Of-Specification results identified by the manufacturer during ongoing stability testing of the affected products,” MCAZ said in a statement issued yesterday.
The affected Nifedipine 10mg tablets are from batches 112033 and 117367, which the regulator said returned out-of-specification results in their dissolution profiles, mainly affecting the early stages of dissolution.
MCAZ said Levodopa/Carbidopa 100mg/25mg tablets from batches 97261, 102600, 102603 and 107232 had developed changes in appearance, with the tablets changing from yellow to dark yellow or brownish at the end of their shelf life.
The Levodopa/Carbidopa 250mg/25mg tablets from batches 99671, 102751 and 102752 also showed a colour change, from blue to yellowish green, together with recurring out-of-specification results associated with a decrease in the Carbidopa assay.
“The Authority has directed all licensed pharmaceutical wholesalers, pharmacies, and public and private clinics and hospitals to immediately cease further distribution and sale of the affected batches and to return any stock in their possession to the supplier,” MCAZ said.
Patients who may have any of the affected medicines have also been advised to stop using them and return them to the pharmacy or health facility where they obtained them.
MCAZ said it would continue monitoring the situation and provide further guidance where necessary.
