Mandate of the Directorate

The Product Safety directorate ensures that all stakeholders, pharmaceutical service providers and the general public receive the right information on medicines.

The directorate also ensures that drug promotional materials are vetted, approved and monitored to ensure that misleading, biased and inaccurate information on medicines is not disseminated. It is also responsible for pharmacovigilance programs, adverse drug reactions reporting, clinical trials monitoring and hosting the National Pharmacovigilance Centre.

Director Product Safety
Miss. Helen Ndagije

NDA-notfound

Manager Post Market Surveillance

NDA-notfound

Manager Pharmaco-vigilance

The general public is hereby informed that a recall directive has been issued by NDA to the Importers/Local Technical Representatives of the manufacturers for the following products.

The public is therefore advised to be vigilant and look out for the recalled products. Information relating to the recalled products should be submitted to National Drug Authority at: Email: druginfo@nda.or.ug

Products Recalled between September 2018 to March 2019

S/NDate InitiatedBrand NameReason/ProblemLTR
113/09/2018Diclofenac InjectionDiscolaration of otherwise colorless solution and appearance of visible particulate matter in the ampoulesHarley's Uganda Ltd
220/09/2018Gentamycin InjectionOccurrence of severe obnoxious Adverse Drug Reactions like Severe headache, blurred vision and sometimes faintingRene Pharmacy Ltd
320/09/2018Gmycin - 80Occurrence of severe obnoxious Adverse Drug Reactions like Severe headache, blurred vision and sometimes faintingAbacus Pharma (U) Ltd
424/10/2018Agocal abletsDiscoloration of the product on storageGittoes Pharmaceuticals Ltd
524/10/2018CeltriaxoneFailure to comply with GMP for injectablesDelmaw Enterprises Limited
624/10/2018ExpenFailure to comply with GMP for injectablesAbacus Pharma (U) Ltd
724/10/2018ProcilinFailure to comply with GMP for injectablesSuper Pharmaceuticals Ltd
824/10/2018Gentamicin InjectionFailure to comply with GMP for injectablesRene Pharmacy Ltd
924/10/2018Artemether injectionFailure to comply with GMP for injectablesRene Pharmacy Ltd
1024/10/2018Vitamin B complex InjectionFailure to comply with GMP for injectablesRene Pharmacy Ltd
1124/10/2018Diclofenac InjectionFailure to comply with GMP for injectablesRene Pharmacy Ltd
1224/10/2018R-ether 80Failure to comply with GMP for injectablesAbacus Pharma (U) Ltd
1324/10/2018Falcimax 600Failure to comply with GMP for injectablesAbacus Pharma (U) Ltd
1424/10/2018Artemether injectionFailure to comply with GMP for injectablesHarleys Uganda Ltd
1524/10/2018Quinine dihydrocloride injectionFailure to comply with GMP for injectablesHarleys Uganda Ltd
1624/10/2018Diclomax 75Failure to comply with GMP for injectablesAbacus Pharma (U) Ltd
1708/11/2018Ibumol suspensionProduct forms cakes and plaques during storageAbacus Pharma (U) Ltd
1809/11/2018M-energex coffee and M-energex capsulesQuality tests indicated that the product is adulterated with TadalafilDewyx International Company
1912/12/2018Gentamicin injectionImmediate serious Adverse Drug reactionsHarley's Uganda Ltd
2018/01/2019Benzathine Benzylpenicillin sodiumProduct failed to comply with specifications for PH tests which were conducted following market complaintsAbacus Pharma (U) Ltd