Drugs From Kenyan Pharmaceutical Firm, Universal Corporation Limited Recalled Over Poor Quality

The Rwanda Food Drug Authority (RFDA) has recalled a Kenyan Pharmaceutical from its stores and this is not the first time the same action is being taken against drugs from the same Kenyan company.

According to RFDA, four bulk batches of pink Fluconazole 200mg tablets imported into the country had a white discoloration.

“Reference is also made to the letter with ref. No UCL/PD/pp/2023/05/043 by Universal Corporation Ltd notifying the recall of Fluconazole 200mg due to discoloration of tablets. Further reference is made to the investigation performed by Rwanda FDA which confirmed that some incriminated batches were imported into Rwanda.” Reads part of the notice seen by Kenya Insights.

“It is with this background that Rwanda FDA recalls from the Rwandan market the following batches of Fluconazole 200mg tablets.” It adds.

“Rwanda FDA instructs all importers, central medical stores, wholesalers, RMS branches, retailers, Public and Private Health Facilities to stop the distribution of the above mentioned batches of fluconazole 200mg tablets and return them to their suppliers for proper management,” read the statement

All the importers and suppliers are supposed to report to RFDA within 10 days from today and as well issue the Health Ministry with quantities returned and final stocks on hand.

It remains unclear if Kenya where the drug is in circulation will also follow suit and recall as well as other countries wit could’ve been possibly supplied to. It’s also unclear whether the company will be subjected to standard checks in the wake of the Rwanda incident.

The firm prides themselves for having produced the first commercial ARVs made in Kenya.

However, in November 2022, the Pharmacy and Poisons Board (PBP) recalled all Tenofovir/Lamivudine/Dolutegravir 300/300/500 mg (TLD) tablets, ARV drugs manufactured by Universal Corporation Limited believed to have compromised safety standards.

The said ARV drugs were packed in a white bottle stamped with the writings on the side.

“The drugs are in a white bottle with black writings on the side and the wordings ‘Universal Corporation Ltd’ (in blue). The recipients are being requested to return the drugs to the facilities.” Pharmacy and Poisons Board (PPB) boss Dr. Fred Siyoi said.

The quality of the ARV drugs was questioned due to discoloration of the induction seal and the tablets changing colour as well as the bottle covers.

The ARV drugs were ordered by the Kenya Medical Supplies Authority (KEMSA) through the Universal Corporation Limited that is prequalified by the World Health Organisation (WHO) and paid by the global fund.

Universal Corporation Limited, the company behind the recalled drug is a Kenyan Pharmaceutical Manufacturing Company based in Kikuyu Township, Kiambu County.