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.


News / Events

Director Product Safety
Miss. Helen Ndagije


Manager Post Market Surveillance


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:

Products Recalled between July to September 2019

S/NDate InitiatedBatch Number/sBrand NameLTRManufacturerReason/Problem
111/07/2019170428Albendastar 10%NILE SERVICES LTDChongquing Factong Animal Pharmaceuticals Co. LtdFailure to comply with specifications for assay tests
211/07/20190014Erazole 2.5ERAM (U) LTDHEBEI YUANZHENG PHARMACEUTICALS COMPANYFailure to comply with specifications for assay tests
329/07/2019QK70373, QK70374, QK70375, QK70504, QK70505, QK70506, QK70515, QK70516, QK71004, QK80522, QK81415TexavirQUALITY CHEMICALS LTDCIPLA QUALITY CHEMICAL INDUSTRIES LIMITEDFailure to comply with specifications for limits of unknown impurity
414/08/2019EM83127BAtazor-RHARLEY'S (U) LTDEmcure pharmaceuticals LtdFailure to comply with specifications for limits for hydroxy Ritonavir impurity
519/08/2019LDC 180182Dolutegravir as SodiumCipla Quality ChemicalsCipla Kurkumbh IndiaFailure to comply with specifications for limits for lead metal impurity

Products recalled between April to June 2019

S/NDate InitiatedBrand NameBatch Number/sLTRManufacturerReason/Problem
102/04/2019Ciproren03718Rene Industries LtdRENE INDUSTRIES LTDFailure to comply with BP specifications for dissolution tests
202/04/2019CiprolebT2817 & T1877ANDYCO PHARMACY (U) LTDLEBEN LABORATORIES PvtFailure to comply with BP specifications for dissolution tests
304/04/2019Sypertix 10% EC8384-515NKLNORBROOK (U) LTDNORBROOK KENYA LTDFailure to comply with CIPAC/WHOPES specifications for tests done for assay
424/05/2019Albevet170724Global Vet (U) LtdThe Arab pesticides and Veterinary Drugs Mfg. Co. LtdFailure to comply with USP specifications for Assay tests
513/06/2019Aspirin delayed release 75mgET-1918035NATIONAL MEDICAL STORESFlagship Biotec Int. Vadodara IndiaLumping of tablets with a pungent smell

Uppsala Reports, the pharmacovigilance magazine from Uppsala Monitoring Centre