Online Reporter
Tendai Gukutikwa
Health Reporter
THE Medicines Control Authority of Zimbabwe (MCAZ) has clarified that nifedipine has not been banned in the country, emphasising that a recent notice applies strictly to a Class II recall of two specific batches that failed routine quality checks.
The regulatory body issued the clarification following widespread public misunderstanding that led some patients to stop collecting or taking their hypertension medication.
MCAZ confirmed that all other batches of nifedipine remain fully approved, safe, and available across Zimbabwe.
According to MCAZ, patients should verify the batch numbers printed on their medication packaging before making any changes to their daily treatment regimens.
“What is needed is to check the batch number of one’s pack. If it is not one of the two recalled, patients should continue taking their medicine. If it matches the batch numbers, take back the medicine to the pharmacy,” said MCAZ in a statement.
The affected nifedipine 10mg items are batches 112033 and 117367, manufactured by Remedica Ltd of Limassol, Cyprus.
Nifedipine is a vital pharmaceutical intervention widely prescribed for long-term high blood pressure management.
The initial recall notice, issued by MCAZ director-general, Mr Richard Rukwata, was triggered by Out-Of-Specification (OOS) results detected by the manufacturer during routine stability testing. The quality issue concerning the two nifedipine batches specifically involved their dissolution profile during early stages, although later dissolution stages remained within required safety specifications.
“The Medicines Control Authority of Zimbabwe (MCAZ) has instituted a Class II recall up to retail level of specified batches of Nifedipine 10mg tablets, Levodopa/Carbidopa 100mg/25mg tablets, and Levodopa/Carbidopa 250mg/25mg tablets manufactured by Remedica Ltd,” reads the statement.
MCAZ directed all licenced pharmaceutical wholesalers, retail pharmacies, and health facilities – both public and private – to immediately halt the sale and distribution of the affected batches and return existing inventory to suppliers.
Patients holding the specified products were instructed to cease usage immediately and return them to their original point of purchase.
Alongside nifedipine, specified batches of Levodopa/Carbidopa – a medication used to treat Parkinson’s disease – were also recalled due to physical appearance changes and active ingredient degradation noted during stability evaluations.
The affected Levodopa/Carbidopa 100mg/25mg stock includes batches 97261, 102600, 102603, and 107232, which exhibited physical discoloration from yellow to dark yellow/brownish toward the end of their shelf life.
For Levodopa/Carbidopa 250mg/25mg, the recall covers batches 99671, 102751, and 102752. These batches displayed a color shift from blue to yellowish-green alongside recurring test results indicating a decrease in Carbidopa assay potency.
MCAZ assured the public that it will continue monitoring the pharmaceutical supply chain and issue additional guidance as necessary.
Healthcare professionals stressed that patients who remain uncertain about their current prescriptions should consult their pharmacist or physician directly rather than abruptly stopping prescribed therapies.
