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 in 2020

S/NDate InitiatedBrand NameBatch Number/sLTRManufacturerReason/Problem
11/28/2020Ciproleb-500T4108ANDYCO PHARMACY (U) LTDLeben laboratories Pvt LtdFailure to comply with BP specifications for dissolution tests
23/9/2020CiprolebT3088 & T4528ANDYCO PHARMACY (U) LTDLeben laboratories Pvt LtdFailure to comply with BP specifications for dissolution tests
33/9/2020Cycloren00118RENE PHARMACY LTDRENE INDUSTRIES LTDFailure to comply with BP specifications for Assay test
43/9/2020TricipRQ707AIVEEN (U) LTDTriveni Formulations Ltd, Surampali - IndiaFailure to comply with BP specifications for uniformity of dosage form, Assay & dissolution
53/16/2020Alamycin 10 injection9231-600ANORBROOK (U) LTDNORBROOK LABS LTD, IRELANDpoor quality issues
66/10/2020Unosure 72DLBK05ABACUS PHARMA (A) LTDAKUMS DRUGS & PHARMACEUTICALS LTD – PLANT 5Failure to comply with Dissolution tests
76/16/2020BetalinctusAllKisakyeKISAKYE INDUSTRIES LIMITEDFailure to comply with Good manufacturing Practices
87/13/2020NetvaicaineSX-19352PLANET PHARMACEUTICALS (U) LTDSWISS GARNIER LIFE SCIENCESSevere neurological adverse drug reactions
97/20/2020Piritex JuniorAllMEDIPHARM SALES LTDMEDIPHARM INDUSTRIES (E.A) LTDPresence os crystalline particulate matter in the syrup
107/27/2020Eazy pillEUG 007AIVEEN (U) LTDCORONA REMEDIES PVT LTDFailure to comply with specifications for dissolution tests
118/3/2020Valcontin9318, 9319, 9320, 9321, 9322, 9323, 9352, 9353, 9355, 9247, 9248, 9249, 9250, 9251, 9252, 9253, 9254, 9255, 9256, 9257SURGIPHARM (U) LTDMODI MUNDIPHARMA PVT. LTDTablets squashed, molten and stuck to the primary packaging
128/18/2020E-J Euro Ject-X Auto disposable syringes20190319Surgimed (U) LtdShanghai International Holdings Corp. GmBH (Europe) Hamburg GermanyFailure of the re-use feature
138/18/2020Revital Syringes205401VRUSHIK INVESTMENTS (U) LTD.Revital Healthcare(EPZ) Ltd - KenyaFailure of the re-use feature
148/26/2020Phenobarbital 200mg/ml0124892, 0122830, 0124140, 0122142LABOREX (U) LTDMartindale Pharma - UKDegradation due to innapropriate environmental conditions while in transit
158/26/2020VermikilE9SGCT005, E9SGCT008ROYAL PHARMA 2011 LTDSYNOKEM PHARMACEUTICALS LIMITEDFailure to comply with USP specifications for Dissolution tests
168/26/2020Abpara28B05620ABACUS PHARMA (A) LTDABACUS PARENTERAL DRUGS LTD (APDL)Severe adverse drug reaction
178/27/2020Vet Fungicare spray, Vet Tick clean spray, Vet healer sprayALLRoyal Agrovet LtdVet Biochem Pvt IndiaUnregistred veterinary products
189/28/2020Alzol-40001619Rene Industries LtdRENE INDUSTRIES LTDFailure to comply wth specifications for dissolution tests (Iternational Pharmacoepia)
199/28/2020Doxyrone-100000780ROYAL PHARMA 2011 LTDAfricure Pharmaceuticals LtdFailure to comply with BP specifications for Uniformity of dosage forms
209/28/2020SpamcilMO210,MO211,MO213,MO214, MO216, MO218ABACUS PHARMA (A) LTDSPARSH BIOTECH PVT LTDPresence of brown lumps in the powder
2110/12/2020Gynozol Ovules201111, 201463, 201464, 201465WIDESPECTRUM ENT. (U) LTDPHARCO PHARMACEUTICALSCapsules melt before use
2210/14/2020Ascorbic acid2001047AIVEEN (U) LTDDAWA LIMITEDColor change of tablets from Orange to Brown
2312/2/2020Xymex dropsC90124MEDVIN PHARMA LTDMEDLEY PHARMACEUTICALS LTDFormation of Black/Brown smudges inside the liquid
2412/10/2020Norotraz 12.5% 40ml8265-501NKL, 8494-501NKL, 9133-501NKLNORBROOK (U) LTDNORBROOK KENYA LTDCrytallization of liquid
2512/14/2020FLUPHENAZINE DECANOATE INJECTION USP 25MG/ML70327GITTOES PHARMACEUTICALS LTDROTEX MEDICA GMBH ARZENEIMITTELWERKStability study failure showing out of Specification (OSS) for the impurity-free Fluphenazine content
2612/14/2020Lidocaine injection 2%GM804, GM805, GM809GITTOES PHARMACEUTICALS LTDUMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA.Adverse drug reactions due to use of the product
2712/17/2020Unibrol5806675 & 5806897DELMAW ENTERPRISES LTDUniversal Corporation Ltd - KenyaColor change of tablets from white to Yellow

Products Recalled in 2019

S/NDate InitiatedBrand NameBatch Number/sLTRManufacturerReason / Problem
102/04/2019Ciproren3718Rene 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
611/07/2019170428Albendastar 10%NILE SERVICES LTDChongquing Factong Animal Pharmaceuticals Co. LtdFailure to comply with specifications for assay tests
711/07/20190014Erazole 2.5ERAM (U) LTDHEBEI YUANZHENG PHARMACEUTICALS COMPANYFailure to comply with specifications for assay tests
829/07/2019QK70373, 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
914/08/2019EM83127BAtazor-RHARLEY'S (U) LTDEmcure pharmaceuticals LtdFailure to comply with specifications for limits for hydroxy Ritonavir impurity
1019/08/2019LDC 180182Dolutegravir as SodiumCipla Quality ChemicalsCipla Kurkumbh IndiaFailure to comply with specifications for limits for lead metal impurity
1118/09/2019WormitaERAM (U) LTDCosmos Ltd - KenyaFailure to comply with specifications for pH tests
1224/09/2019AgovirGITTOES PHARMACEUTICALS LTDAgog Pharma LtdFailure to comply with BP specifications for dissolution
1314/10/2019All products suspendedVITACARE LTDGRAND PHARMACEUTICAL (CHINA) CO LIMITEDNon compliance with GMP as per NDA Guidelines
1429/10/2019Hydrogen Peroxide MouthwashKwality AfroAsia LtdKWALITY AFROASIA LTD.Failed to comply with specifications for Assay tests
1530/10/2019Life guardMARIE STOPES PHARMACYMHL Health Care Ltd - IndiaFailed to comply with specifications for absence of holes and bust strength
1631/10/2019Ashiaben 2.5%MTK UGANDA LTDASHISH LIFE SCIENCES PVT LTDFailure to comply with specifications for pH tests
1711/11/2019ALL products suspendedASTRA PHARMA (U) LTDZhejiang Ruixin Pharmaceutical Co. Ltdnot complying with GMP requiremnets as per NDA guidelines
1825/11/2019DabendazoleSUPER MEDIC LTDMEDISEL KENYA LIMITEDFailure to comply with specifications for Assay and pH
1919/12/2019Olfen 100 DecapGOODMAN INTERNATIONAL LTDACINO PHARMA AGOOS results for dissolution tests during stability testing

Products Recalled in 2018

S/NDate InitiatedBrand NameBatch Number/sManufacturerCompany nameReason for recall
1January 18, 2018Male Latex Black Studded Condoms17N0452Karex Industries SDN BHDAfford/UHMGFailure to comply with ISO 4074:2015/WHO 2010 specifications for airburst volume and pressure
2January 29, 2018Masculan (Pink colored, ribbed & dotted)17A28M.P.I Pharmaceuticals GmbH, GermanyGama Pharmaceuticals (U) ltdFailure to comply with manufacturer's specifications for lubricant quality
3January 31, 2018Pre-powdered Surgical glovesARP414Lars Medicare PVT LtdRoyal Pharma 2011 LtdFailure to comply with ISO 10282, ASTM D3577 for freedom from holes.
4January 31, 2018Medisafe (Pre-powdered surgical latex gloves)ARP452, ARP454 & ARP455Lars Medicare PVT LtdAbacus Pharma (A) LtdFailure to comply with ISO 10282, ASTM D3577 fro freedom from holes test
5February 12, 2018Masculan condoms (colored, non-colored, dotted, ribbed, flavoured)17E15, 16H30, TN28471, TN28472M.P.I Pharmaceuticals GmbH, GermanyGama Pharmaceuticals (U) LtdFailure to comply with manufaturer's specifications for lubricant quality
6February 12, 2018Rhinathiol 5% Sugar free syrup6K0491 & 6K0531NATTERMAN & CIE , COLOGNE , GERMANYLaborex (U) LtdPresence of visible brownish particles in the solution
7February 19, 2018Mesotrim00117, 00217 & 00317Lifeway Pharmaceuticals Ltd-UgandaLifeway Pharmaceuticals LtdFailure to comply with dissolution test per USP specifications
8February 20, 2018Zepar124Shaigan Pharmaceuticals PVT LtdHealthcare (U) LtdFailure to comply with USP specifications for pH
9February 22, 2018AlbaxBX.05.17Medipharm industries Ltd-UgandaMedipharm industries LtdFailure to comply with USP specifications for pH
10February 22, 2018Pre-powdered latex surgical glovesARP415Lars Medicare PVt LtdRoyal Pharma 2011 LtdFailure to comply with ISO 10282, ASTM D3577 for freedom of holes
11February 22, 2018Medicare powdered latex surgical glovesARP438Lars medicare PVT LtdMedvin Phrma LtdFailure to comply with ISO 10282, ASTM D3577 for freedom from holes test
12February 22, 2018Zepar125Shaigan Pharmaceuticals PVT LtdHealthcare (U) LtdFailure to comply with USP specifications for pH
13February 22, 2018Armour (powdered latex surgical gloves)ARP423ASMA Rubber products LtdSurgimed Uganda LtdFailure to comply with ISO 10283, ASTM D3577 for freedom from holes
14February 22, 2018Pre-powdered Latex surgical glovesARP456Lars medicare PVT LtdAbacus Pharma (A) LtdFailure to comply with ISO 10282, ASTM D3577 for freedom of holes
15February 23, 2018Masculan (pur superfime & frutti edition)CR29581 & 16H34M.P.I Pharmaceuticals GmbH, GermanyGama Pharmaceuticals (U) LtdFailure to comply with manufacturer's specifications for lubricant quality
16February 26, 2018Non colored contoured condoms160323Dongkuk Vietnam co. LtdUHMG for Ministry of HelathFailure to comply with ISO 4074:2015/WHO 2010 specifications for airburst volume and pressure
17February 26, 2018Broche (Powdered & Nitrile) examination gloves12201703(medium), 12201703(large), 1221702(medium) & 12201702(large)MalaysiaPrecise Diagnostics & medical Supplies LtdFailure to comply with ISO 1119-1, ASTM D3578 for freedom from holes test
18February 26, 2018Paracetamol tablets160551Zheijiang Ruixin Phamraceuticals Co. LtdAstra Pharma (U) LtdFailure to comply with BP specifications for Assay
19March 5, 2018K-Albendazole016Kwality Afro-Asia LtdKwality Afro-Asia LtdFailure to comply with USP specifications for Assay
20March 6, 2018Derma-1NF 601Triveni Formulations LtdSuper Medic LtdFailure to comply with BP specifications for Assay
21March 7, 2018Needles on 2ml syringes20170109 & 20170820Anthui Tiankang Medical technology Co. LtdMaisha Medical suppliesFailure to comply with manufacturer's specifications for lubricant quality
22March 19, 2018Hydrocortisone sodium succinate7000415 & 7000215Karnataka Antibiotics & Pharmaceuticals LtdTata (U) LtdFailure to comply with USP specifications for appearance on reconstitution and pH
23March 21, 2018AgomolL73016Agog Pharma LtdGittoes Pharmaceuticals LtdFailure to comply with BP specifications for Assay
24March 21, 2018Derma-1NF 602 & NF 603Triveni Formulations LtdSuper Medic LtdFailure to comply with BP specifications for Assay
25April 3, 2018Masculan Gold Anatomic contoured male latex condomsAP31221M.P.I Pharmaceuticals GmbH, GermanyGama Pharmaceuticals LtdFailure to comply with manufacturer's specifications for lubricant quality
26April 3, 2018Alzol - 40003217Rene Industries LtdRene Industries LtdWrong information leaflet in the product which is misleading
27April 11, 2018Nulife Latex surgical glovesT01900MRK Healthcare PVTJoint Medical StoresFailure to comply with manufacturer's specifications/ISO 10282 for dimensions test.
28April 24, 2018Revital Re-use syringes054117 & 054417Revital Healthcare (EPZ) LtdAbacus Pharma (A) LtdParts of the plunger peel off into the contents of the syringe
29April 24, 2018Hydralazine 20mg/mlSX-17262Swiss Parenterals PVT LtdShreeji Pharmaceuticals LtdPresence of growth and visible particulate matter in the product
30May 18, 2018Gentamycin Injection171225 & 171226Zhejiang Ruixin Pharmaceuticals Co. LtdAstra Pharma (U) LtdIllegible and faint labels on the ampoules
31May 18, 2018SequozoleLQ/16047/01 & LQ/16050/01Alivira Animal helath LtdEram UgandaIllegible labels, and easily erased (dates of manufacturers and expiry dates)
32May 22, 2018Gentamicin Injection170390 & 170929Anhui Chengshi Manufacture Medical Co. LtdRENE PHARMACY LTDImmediate adverse events upon administered: Severe headache, dizziness, blurred vision, fainting in some patients, rash and itching.
33May 28, 2018Vitamin B complex Injection171231 & 161223Zhejiang Ruixin Pharmaceuticals Co. LtdAstra Pharma (U) LtdIllegible and easily erased labels on the ampoules
34May 30, 2018KAM-O MintKOT 16028, 16029 & 16034Kampala Pharmaceuticals Industries LtdKampala Pharmaceuticals Industries LtdFailure to comply with specifications for hardness test. The tablets are very hard to chew.
35May 31, 2018BimatrazB031117ABimeda Chemicals Export - IrelandBimeda (U) LtdFailure to comply with USP specifications for the Assay test
36May 31, 2018Latex Surgical Gloves20160920Jiangsu Changzou Yihua Sanitation Material Co. Ltd - ChinaNational Medical StoresFailure to comply with ASTM D3577 specifications for freedom from holes test.
37June 1, 2018Gentamicin Injection1703106SHANDONG XIER KANGTAI PHARMACEUTICALS COMPANY LTDABACUS PHARMA (A) LTDImmediate adverse events upon administered: Severe headache, dizziness, blurred vision, fainting in some patients, rash and itching.
38June 22, 2018Vitamin B complex171230Zhejiang Ruixin Pharmaceuticals Co. LtdAstra Pharma (U) LtdFailure to comply with labelling requirments for use of indelible Ink markings for product labels.
39July 25, 2018Valsar Denk: 80, 160, 320 & Covalsar denk: 80/12.5, 160/12.5, 320/12.5AllDenk Pharma Gmbh & Co. kgBenle Consults LtdContamination with carcinogenic impurity called NMDA
40July 31, 2018Valsar 80 & Valsar 160All BatchesHetero Labs Ltd UNIT VAbacus Pharma (U) LtdContamination with carcinogenic impurity called (NMDA)
41August 1, 2018Diclomax - 75170409Jiangsu Pengyao Pharmaceutical Co. LtdAbacus Pharma (U) LtdProduct changes color on storage and presence of visible particulate matter
42August 13, 2018Diclomax - 75AllJiangsu Pengyao Pharmaceutical Co. LtdABACUS PHARMA (A) LTDPoor quality
43August 13, 2018Hydrocortisone Sodium SuccinateAll BatchesSwiss Parenterals PVT ltdShreeji Pharmaceuticals LtdContinued failure to comply with quality specifications
44August 16, 2018Furosemide injection BP 10mg/2ml180120Grand Pharmaceuticals Co. LtdVitacare Pharmacy LtdMisleading information leaflet
45August 16, 2018Ocucycline 1%C971Centaur Pharmaceuticals PVT ltdGittoes Pharmaceuticals LtdChange in color from yellow to brown
46August 23, 2018Agovir TabletsT72074Agog Pharma LtdGittoes Pharmaceuticals LtdFailure to comply with the dissolution test.
47August 31, 2018Hydralazine 20mg/mlSX-17262 and All batchesSwiss Parenterals PVT ltdShreeji Pharmaceuticals LtdVisible particulate matter in the injectable solution
48September 13, 2018Diclofenac InjectionAll batchesJiangsu Pengyao Pharmaceutical Co. LtdHarley's Uganda LtdDiscolaration of otherwise colorless solution and appearance of visible particulate matter in the ampoules
49September 20, 2018Gentamycin InjectionAllAnhui Chengshi Manufacture Medical Co. LtdRene Pharmaceuticals LtdImmediate adverse events upon administered: Severe headache, dizziness, blurred vision, fainting in some patients, rash and itching.
50September 20, 2018Gmycin-80ALLJiangsu Pengyao Pharmaceutical Co. LtdAbacus Pharma (U) LtdImmediate adverse events upon administered: Severe headache, dizziness, blurred vision, fainting in some patients, rash and itching.
51September 20, 2018Gentamycin InjectionAll batchesAnhui Chengshi Manufacture Medical Co. LtdRene Pharmaceuticals LtdImmediate adverse events upon administered: Severe headache, dizziness, blurred vision, fainting in some patients, rash and itching.
52October 24, 2018R-ether, Gmycin-80, Falcimax-600, Artemether inj, Quinine dihydrochloride & Diclomax-75AllJiangsu Pengyao Pharmaceutical Co. LtdAbacus Pharma (U) LtdFailure to comply with GMP specifications
53October 24, 2018Celtriaxone, Expen & procilinALLSHANDONG XIER KANGTAI PHARMACEUTICALS COMPANY LTDAbacus Pharma (U) Ltd, Delmaw Limited, Royal Pharma 2011 Ltd & Super PharmacyFailure to comply with GMP specifications
54October 24, 2018Gentamicin injection, Artemether inj, Vitamin B inj & Diclofenac sodiumALLAnhui Chengshi Manufacture Medical Co. LtdRENE PHARMACY LTDFailure to comply with GMP specifications
55October 24, 2018Agocal abletsT61106Agog Pharma LtdGittoes Pharmaceuticals LtdDiscoloration of the product on storage
56November 8, 2018Ibumol suspensionCK0238CAJANTA PHARMA LTDABACUS PHARMA (A) LTDProduct forms cakes and plaques during storage
57November 9, 2018M-energex coffee and M-energex capsules136868 & SE18J276Bio Gallery SDNDewyx International CompanyQuality tests indicated that the product is adulterated with Tadalafil
58December 12, 2018Gentamicin injectionALLGRAND PHARMACEUTICAL (CHINA) CO LIMITEDHARLEY'S (U) LTDImmediate adverse events upon administered: Severe headache, dizziness, blurred vision, fainting in some patients, rash and itching.