The Pharmacy and Medicines Regulatory Authority (PMRA) has ordered a recall of all ActrapidSolube Insulin— batch numbers JT6R236, KS 6BR28 and KL3BC30— whose labels are suspected to have been tampered with.
The authority says its preliminary investigations indicate that the falsified batches were sourced locally and were supplied to Kamuzu Central Hospital, Queen Elizabeth Central Hospital, Zomba Central Hospital, Malamulo and Mulanje mission hospitals.
It indicates that the facilities have been informed to quarantine the concerned batches.
“The authority is therefore urging all facilities supplied with the insulin bearing the above batch numbers to immediately recall the insulin from all user points including patients. All patients in possession of the insulin with above details are advised to immediately stop using it and consult their respective health practitioners for replacement,” reads a statement which acting Director General Charles Chimenya has signed on the authority’s official Facebook page.
The statement says PMRA is not ruling out the possibility of a mix-up between insulin with authentic batch details and the one whose batch details are suspected to have been tampered with.
The statement says PMRA inspectors are working with law enforcement agencies to get to the bottom of the matter and ensure that all those involved in the supply chain of the affected insulin are prosecuted in accordance with provisions of the PMRA Act and other relevant laws.
“The authority is reminding stakeholders and the public that distributing or selling of expired drugs, tampering with and/or falsifying medicine labels are serious offences which, upon conviction, attract up to K10 million fine and 10 years imprisonment.
“The authority remains steadfast in ensuring that medicines, allied substances and vaccines being used in the country are of acceptable quality, safe and efficacious in line with our mandate,” the statement reads.