MCAZ Recalls Captopril Tablets Over Quality Issues

By Staff Reporter

Yesterday, the Medicines Control Authority of Zimbabwe (MCAZ) announced a Class II immediate recall of one particular batch of Captopril 25mg Tablets made by Torrent Pharmaceuticals Ltd, India. The batch number, B520K001, was recalled because the product received an out-of-specification (OOS) result for disulfide content, an essential quality attribute.

In a press statement by Director General Mr. Richard T. Rukwata, the MCAZ reported that the OOS result (OOS No: OOS/BST/25/004) suggests possible non-compliance with quality specifications. The authority warned that the non-compliance “may lead to loss of efficacy and possible risk to patient safety.”

Class II recall involves retail level action where all the licensed pharmaceutical wholesalers, pharmacies, and public and private clinics must quarantine the batch at a time and discontinue its distribution.

MCAZ is requesting that all health outlets with stock of Captopril 25mg Tablets, Batch: B520K001, discontinue dispensing them immediately. In addition, the authority also requests that the public in possession of tablets of this particular batch return them to the pharmacy where they bought them or the MCAZ.

The regulatory agency assured the public that it is collaborating closely with Torrent Pharmaceuticals Ltd and its local distributor in an effort to implement the effective and prompt recall of the suspect drug from the Zimbabwean market.

“The Authority remains committed to ensuring safety, quality, and efficacy of all medicines,” MCAZ stressed in a statement.

This recall is an important step in ensuring public health protection and is proof of the commitment of the MCAZ to guarantee the quality of medicinal products on the market. Health professionals and consumers should be cautious and follow guidelines issued by the MCAZ in order to counteract any likely harm caused by the affected batch of Captopril tablets.