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 as at July – August 2018

S/NBRAND NAMEREASON / PROBLEM
1Diclofenac (Diclomax-75) Injection. Batch 170409, manufactured by Jiangsu Pengyao Pharmaceuticals Co Ltd (China)Poor quality (product changed color and developed brown soluble crystals)
2Furosemide B.P. 10mg/2ml Injection. Batch 180120, Manufactured by Grand Pharmaceutical (China) Co., LtdMismatching information on PIL and that on primary and secondary packaging
3Tetracycline Hydrochloride Ophthalmic Ointment USP 1%. Batch C971, Manufactured by Centaur Pharmaceuticals PVT. Ltd (India)Poor quality (Product changed color from yellow to brown)

Products which were suspended due to severe side effects and poor quality

S/NPRODUCT NAMEMANUFACTURERSTRENGTHREASON FOR SUSPENSION
1Gentamycin InjectionAnhui Chengshi Manufacture Medicine, Co. Ltd. (China)80mg/2mlSeveral safety reports received (reports of characteristic serious adverse events following use of product)
2Gmycin-80Jiangsu Pengyao Pharmaceuticals Co. (China)80mg/2mlSeveral safety reports received (reports of characteristic serious adverse events following use of product)
3Hydrocortisone Sodium Succinate injectionKarnataka Antibiotics and Pharmaceuticals Ltd. (India)100mgPoor quality (complaints on quality and the product continuously failed QC tests)
4Diclofenac injectionJiangsu Pengyao Pharmaceuticals Co. Ltd, (China)75mg/3mlPoor quality (continued receipt of market complaints on quality)

Products Recalled as at April – May 2018

S/NDATE INITIATEDBRAND NAMEREASON / PROBLEMLTR
105/03/2018K-AlbendazoleLFailure to comply with USP specifications for AssayKwality Afro-Asia Ltd
206/03/2018Derma-1Failure to comply with BP specifications for AssaySuper medic
307/03/2018Needles on 2ml syringesFailure to comply with manufacturer's specifications and ISO 7864 on needle point testMaisha Medical supplies
419/03/2018Hydrocortisone sodium succinateFailure to comply with USP specifications for appearance on reconstitution and pHTata (U) Ltd
521/03/2018AgomolFailure to comply with BP specifications for AssayGittoes Pharmaceuticals Ltd
621/03/2018Derma-1Failure to comply with BP specifications for AssaySuper Medic Ltd
703/04/2018Masculan Gold Anatomic contoured male latex condomsFailure to comply with manufacturer's specifications for lubricant qualityGama Pharmaceuticals Ltd
803/04/2018Alzol - 400Wrong information leaflet in the product which is misleadingRene Industries Ltd
911/04/2018Nulife Latex surgical glovesFailure to comply with manufacturer's specifications/ISO 10282 for dimensions test.Joint Medical Stores
1015/04/2018Masculan Gold (atomic) condoms Masculan Gold (luxury) condoms Musculan dotted condoms musculan sensitive condoms musculan pink colored ribbed condomsFailure to comply with manufaturer's specifications for lubricant qualityGama Pharmaceuticals
1124/04/2018Hydralazine 20mg/ml injPresence of growth and visible particulate matter in the productShreeji Pharmaceuticals Ltd
1224/04/2018Revital Re-use syringesParts of the plunger peel off into the contents of the syringeAbacus Pharma (A) Ltd
1318/05/2018Sequozole tablets (Vet)Illegible labels, and easily erased (dates of manufacturers and expiry dates)Eram Uganda
1418/05/2018Gentamycin InjectionIllegible and faint labels on the ampoulesAstra Pharma (U) Ltd
1528/05/2018Vitamin B complex InjectionIllegible and easily erased labels on the ampoulesAstra Pharma (U) Ltd
1630/05/2018Kam-O mint tabletsFailure to cmply with specifications for hardness test.Kampala Pharmaceuticals Industries Ltd