MCAZ Issues Public Alert On Recall Of Benylin Cough Syrup

By Judith Matanire

The Medicines Control Authority of Zimbabwe (MCAZ) issued a public alert today regarding the recall of Benylin Paediatric 100ml Syrup, batch number 329304, manufactured by Johnson and Johnson.

This critical communication was received from the National Agency for Food and Drug Administration (NAFDAC) of Nigeria, following Nigeria’s recent recall of J&J children’s cough syrup last week over the presence of a toxic substance.

The identified contaminant, Diethylene glycol, poses severe health risks, including abdominal pain, vomiting, diarrhoea, and acute kidney injury.

The South African Health Products Regulatory Authority (SAHPRA) and the manufacturer confirmed an additional affected batch, totaling two: 329303 and 329304. Johnson and Johnson is collaborating with regulatory authorities to investigate the safety issue and implement necessary measures.

The company reaffirmed its commitment to product quality and safety, apologizing for any inconvenience caused. Despite Benylin Paediatric Syrup being registered for use in Zimbabwe in 2023, MCAZ’s import records do not show the entry of these two batches, raising concerns about potential illegal distribution.

As a precautionary measure, MCAZ urges the public to report encounters with these batches to authorities or healthcare providers immediately and avoid administering them to children. Stakeholder cooperation is essential in safeguarding citizens’ access to safe medicines.

MCAZ commits to enhancing market surveillance through rigorous inspections and awareness initiatives.

The Authority underscores adherence to WHO guidelines and advises procurement of medicines from licensed sources for enhanced monitoring. Mr. Richard Rukwata, Director-General of MCAZ, reaffirmed the Authority’s mission to ensure the safety, efficacy, and quality of medical products. Collaboration with law enforcement remains pivotal in combating substandard and falsified health products. *Nhau/Indaba*

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