By Michael Gwarisa
The Medicines Control Authority of Zimbabwe (MCAZ) has issued a Class II recall of Torrent Captopril 25mg tablets, a widely used medication for high blood pressure (hypertension) and heart failure, due to a detected quality defect that could compromise its safety and effectiveness.
The recall affects Batch B520K001, manufactured by Torrent Pharmaceuticals Ltd of India, and is being carried out up to the retail level, including pharmacies, hospitals, and clinics.
In an official statement, MCAZ Director Mr. Richard Rukwata confirmed the recall was triggered after the affected batch failed routine quality tests.
The recall was prompted by an Out-Of-Specification result for Captopril disulfide, which is a crucial marker of the medicine’s stability and potency,” said Mr. Rukwata. “Failure to meet these specifications may lead to reduced effectiveness of the drug, posing a risk to patients who depend on it for controlling blood pressure and managing heart failure.”
Captopril belongs to a class of drugs known as ACE inhibitors and is commonly prescribed to patients for the treatment of hypertension and certain types of heart disease. If the medication fails to perform as intended, it may lead to poor blood pressure control, increasing the risk of stroke, heart attack, or kidney complications.
MCAZ is urging pharmacies, public and private hospitals, clinics, and all licensed pharmaceutical wholesalers to immediately quarantine and cease distribution of the affected batch. The Authority also calls on members of the public who may have purchased this specific batch to return it to their pharmacy of purchase or directly to MCAZ.
“The safety of patients is our top priority,” Mr. Rukwata emphasized. “We are working closely with Torrent Pharmaceuticals and their local distributors to ensure the rapid and complete removal of this defective batch from the market. Such swift action ensures that patients are not exposed to potential harm.”
This Class II recall is typically applied when a product defect may cause temporary or medically reversible health consequences, or where the probability of serious health issues is relatively low. However, given the critical nature of Captopril in managing cardiovascular conditions, any compromise in quality is treated with the utmost seriousness.
Mr. Rukwata also reassured the public that alternative batches of Captopril and other ACE inhibitors remain available and are not affected by this recall.
“We encourage patients not to panic. Those on Captopril therapy should consult their pharmacists or healthcare providers for alternative supplies or equivalent medication,” he added.
The Authority reiterated its commitment to maintaining rigorous pharmacovigilance systems and ensuring the availability of safe, high-quality, and effective medicines across Zimbabwe.
“Our post-market surveillance systems are active and continuously monitoring product quality. We remain committed to ensuring that only products that meet stringent safety and quality standards are available to the Zimbabwean public,” said Mr. Rukwata.
For further inquiries or to report possession of the affected batch, the public is encouraged to contact MCAZ via their toll-free line or visit their official website.
