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
| S/N | Date Initiated | Brand Name | Batch Number/s | LTR | Manufacturer | Reason/Problem |
|---|---|---|---|---|---|---|
| 1 | 15/08/2022 | Mediworld Auto Disposable syringes | 210301 | Mediworld Pharma Africa Ltd | Anhui Tiankang Medical Technology Co. Ltd - No 228 Weiyi Rd, Economic Development Zone, Tiankang City, Anhui, China | Failure of ISO 7886-4 specification for reuse prevention feature |
| 2 | 19/08/2022 | OXYTOCIN INJECTION 10 IU | 121016 | GITTOES PHARMACEUTICALS LTD | SAKAR HEALTHCARE PVT LIMITED - INDIA | PRODUCT BATCH FAILED THE USP SPECIFICATIONS FOR THE VISIBLE PARTICULATE MATTER. |
| 3 | 19/08/2022 | AD SYRINGE WITH 3ML NEEDLE | 2001K1 | BIOMED AFRICA LTD | EL DAWLIAICO INTERNATIONAL COMPANY FOR MEDICAL NECESSITIES - EGYPT | PRODUCT BATCH FAILED THE ISO 7886-4 SPECIFICATION FOR REUSE PREVENTION FEATURE |
| 4 | 22/08/2022 | ENDOSPEC 10% 1 LTR PACK | 2008019 | BIMEDA (U) LTD | MEDISEL KENYA LIMITED | PRODUCT FAILED USP SPECIFICATIONS FOR PH |
| 5 | 22/08/2022 | OXYTOCIN INJECTION 10 IU | 128109 | TATA (U) LTD | GLAND PHARMACEUTICALS LTD - INDIA | PRODUCT BATCH FAILED USP SPECIFICATIONS FOR PARTICULATE MATTER |
| 6 | 22/08/2022 | TOTO GRIPE WATER | A21017 & A21018 | METRO PHARMACEUTICALS LTD | KESAR PHARMA PVT LTD - INDIA | VISIBLE PARTICULATE MATTER |
| 7 | 22/08/2022 | ASPIRIN 300MG | ALL BATCHES | HARLEY'S (U) LTD & ROYAL PHARMA 2011 LTD | LABORATORY & ALLIED LTD KENYA | RECRYSTALLIZATION OF TABLETS |
| 8 | 02/09/2022 | Revital Syringes | 215307 | ROYAL PHARMA 2011 LTD | Revital Healthcare (EPZ) Ltd Kenya | Failure to comply with ISO 7886-4 specification for Re-use prevention feature |
| 9 | 10/09/2021 | Hydrogen Peroxide | 17 | Smartcare Ltd | Smartcare Ltd | The product does not foam |
| 10 | 17/09/2021 | Zenvac (Bupivacaine Hydrochloride 5mg) | LEZ20053 | Lloyds Pharmacy Ltd | Zen Pharma Pvt Ltd. | Adverse drug reactions including hallucinations, aggressive behaviour, confusion |
| 11 | 23/09/2021 | D-Worm | D22719001 | Shurik Ltd | Torque Pharmaceuticals Ltd - India | Failure to comply with international pharmacopoeia specifications for Dissolution test. |
| 12 | 12/10/2021 | Losar Denk 50, 100 and Colosar Denk 50,100 | All | Benle Consult Ltd | Denk Pharma Gmbh & Co. Kg | Presence of genotoxic impurity characterized as 4-Chloro Azodomethyltetrazole |
| 13 | 30/11/2021 | Gastrogel suspension | GT 03.20 | Medipharm Sales Ltd | Medipharm Industries (E.A) Ltd | Product caked and cannot be suspended on shaking |
| 14 | 30/11/2021 | Vance hand sanitizer | 01-06-001 | Vance Investments Ltd | Vance Investments Ltd | Failure to comply with specification for presence of particulate matter as per Uganda Standard US EAS 789:2013 |
| 15 | 30/11/2021 | B-Safe | 49072021 | Reddy'S Pharma Ltd | Reddy'S Pharma Ltd | Faillure to comply with specifications for Presence of particulate matter as per Uganda Standard US EAS 789:2013 |
| 16 | 02/02/2022 | Rene hand sanitizer | 2521 | Rene Pharmacy Ltd | Rene Industries Ltd | Results from the laboratory indicate that the batch failed to comply with US EAS 789:2013 specifications for pH tests |
| 17 | 10/02/2022 | Cotrimoxazole 960mg | K59221002 | Tata (U) Ltd | Kopran Limited, | Moulding of the tablets |
| 18 | 12/04/2022 | Panto Denk | 3940 | Benle Consult Ltd | Denk Pharma Gmbh & Co. Kg | OOS incident during ongoing stabilty study which showed discolaration of tablets caused by oxidation of iron salts due to moisture |
| 19 | 24/06/2022 | Amitix 125G/L | 18023412 & BE 1900550 | Nile Services Ltd | Alfasan Int. B.V, Chimac Sa Belgium | Failure to comply with the USP sepcifications for Assay tests |
| S/N | Date Initiated | Brand Name | Batch Number/s | LTR | Manufacturer | Reason/Problem |
|---|---|---|---|---|---|---|
| 1 | 9/10/2021 | Hydrogen Peroxide | All batches | Smartcare Ltd | Smartcare Ltd | Unlicensed manufacturer and poor quality products |
| 2 | 9/17/2021 | Zenvac (Bupivacaine Hydrochloride 5mg) | LEZ20053 | Lloyds Pharmacy Ltd | ZEN PHARMA PVT LTD. | Severe Adverse Drug Reactions |
| 3 | 9/23/2021 | D-Worm | D22719001 | SHURIK LTD | Torque Pharmaceuticals Ltd - India | Failure to comply with international pharmacopoeia specifications for Dissolution test |
| 4 | 4/20/2021 | Norotraz 12.5% (40ml & 100ml) | Resource codes: 151001000 & 151001100 | NORBROOK (U) LTD | NORBROOK KENYA LTD | Presence of crystalline particulate matter |
| 5 | 4/20/2021 | EXT set 200cm P-Disc (G30402M) & Gp Series infusion Set 2 Ssy singles (60093E) | 556518 & 1015275 respectively | PHILLIPS PHARMACEUTICALS (U) LTD | Becton Dickinson (BD) | Compromised sterility |
| 6 | 6/17/2021 | Endospec 10 % 1 litre | 1911013 | BIMEDA (U) LTD | MEDISEL KENYA LIMITED | Failure to comply with USP specifications for pH |
| 7 | 6/17/2021 | Endospec 10 % 1 litre | 1907042 | BIMEDA (U) LTD | MEDISEL KENYA LIMITED | Failure to comply with USP specifications for pH |
| 8 | 6/22/2021 | Medisolone 15 syrup | MS 01.20 | MEDIPHARM SALES LTD | MEDIPHARM INDUSTRIES (E.A) LTD | Relabelling of product batch number, manufacuring and expiry dates contrary to GMP requirements |
| 9 | 7/22/2021 | Dawaprom syrup | 1910286 & 2004051 | SUPER MEDIC LTD | DAWA LIMITED | Failed assay tests during stability studies |
| 10 | 7/29/2021 | D-Worm | D22718001 | SHURIK LTD | Torque Pharmaceuticals Ltd | Failure to comply with international pharmacopoeia specification for dissolution tests |
| 11 | 7/29/2021 | Vorm-400 | EUGV019002 | ROYAL PHARMA 2011 LTD | RAVIAN LIFE SCIENCE PVT LTD | Failure to comply with International Pharmacopoeia specifications for dissolution tests |
| S/N | Date Initiated | Brand Name | Batch Number/s | LTR | Manufacturer | Reason/Problem |
|---|---|---|---|---|---|---|
| 1 | 1/28/2020 | Ciproleb-500 | T4108 | ANDYCO PHARMACY (U) LTD | Leben laboratories Pvt Ltd | Failure to comply with BP specifications for dissolution tests |
| 2 | 3/9/2020 | Ciproleb | T3088 & T4528 | ANDYCO PHARMACY (U) LTD | Leben laboratories Pvt Ltd | Failure to comply with BP specifications for dissolution tests |
| 3 | 3/9/2020 | Cycloren | 00118 | RENE PHARMACY LTD | RENE INDUSTRIES LTD | Failure to comply with BP specifications for Assay test |
| 4 | 3/9/2020 | Tricip | RQ707 | AIVEEN (U) LTD | Triveni Formulations Ltd, Surampali - India | Failure to comply with BP specifications for uniformity of dosage form, Assay & dissolution |
| 5 | 3/16/2020 | Alamycin 10 injection | 9231-600A | NORBROOK (U) LTD | NORBROOK LABS LTD, IRELAND | poor quality issues |
| 6 | 6/10/2020 | Unosure 72 | DLBK05 | ABACUS PHARMA (A) LTD | AKUMS DRUGS & PHARMACEUTICALS LTD PLANT 5 | Failure to comply with Dissolution tests |
| 7 | 6/16/2020 | Betalinctus | All | Kisakye | KISAKYE INDUSTRIES LIMITED | Failure to comply with Good manufacturing Practices |
| 8 | 7/13/2020 | Netvaicaine | SX-19352 | PLANET PHARMACEUTICALS (U) LTD | SWISS GARNIER LIFE SCIENCES | Severe neurological adverse drug reactions |
| 9 | 7/20/2020 | Piritex Junior | All | MEDIPHARM SALES LTD | MEDIPHARM INDUSTRIES (E.A) LTD | Presence os crystalline particulate matter in the syrup |
| 10 | 7/27/2020 | Eazy pill | EUG 007 | AIVEEN (U) LTD | CORONA REMEDIES PVT LTD | Failure to comply with specifications for dissolution tests |
| 11 | 8/3/2020 | Valcontin | 9318, 9319, 9320, 9321, 9322, 9323, 9352, 9353, 9355, 9247, 9248, 9249, 9250, 9251, 9252, 9253, 9254, 9255, 9256, 9257 | SURGIPHARM (U) LTD | MODI MUNDIPHARMA PVT. LTD | Tablets squashed, molten and stuck to the primary packaging |
| 12 | 8/18/2020 | E-J Euro Ject-X Auto disposable syringes | 20190319 | Surgimed (U) Ltd | Shanghai International Holdings Corp. GmBH (Europe) Hamburg Germany | Failure of the re-use feature |
| 13 | 8/18/2020 | Revital Syringes | 205401 | VRUSHIK INVESTMENTS (U) LTD. | Revital Healthcare(EPZ) Ltd - Kenya | Failure of the re-use feature |
| 14 | 8/26/2020 | Phenobarbital 200mg/ml | 0124892, 0122830, 0124140, 0122142 | LABOREX (U) LTD | Martindale Pharma - UK | Degradation due to innapropriate environmental conditions while in transit |
| 15 | 8/26/2020 | Vermikil | E9SGCT005, E9SGCT008 | ROYAL PHARMA 2011 LTD | SYNOKEM PHARMACEUTICALS LIMITED | Failure to comply with USP specifications for Dissolution tests |
| 16 | 8/26/2020 | Abpara | 28B05620 | ABACUS PHARMA (A) LTD | ABACUS PARENTERAL DRUGS LTD (APDL) | Severe adverse drug reaction |
| 17 | 8/27/2020 | Vet Fungicare spray, Vet Tick clean spray, Vet healer spray | ALL | Royal Agrovet Ltd | Vet Biochem Pvt India | Unregistred veterinary products |
| 18 | 9/28/2020 | Alzol-400 | 01619 | Rene Industries Ltd | RENE INDUSTRIES LTD | Failure to comply wth specifications for dissolution tests (Iternational Pharmacoepia) |
| 19 | 9/28/2020 | Doxyrone-100 | 000780 | ROYAL PHARMA 2011 LTD | Africure Pharmaceuticals Ltd | Failure to comply with BP specifications for Uniformity of dosage forms |
| 20 | 9/28/2020 | Spamcil | MO210,MO211,MO213,MO214, MO216, MO218 | ABACUS PHARMA (A) LTD | SPARSH BIOTECH PVT LTD | Presence of brown lumps in the powder |
| 21 | 10/12/2020 | Gynozol Ovules | 201111, 201463, 201464, 201465 | WIDESPECTRUM ENT. (U) LTD | PHARCO PHARMACEUTICALS | Capsules melt before use |
| 22 | 10/14/2020 | Ascorbic acid | 2001047 | AIVEEN (U) LTD | DAWA LIMITED | Color change of tablets from Orange to Brown |
| 23 | 12/2/2020 | Xymex drops | C90124 | MEDVIN PHARMA LTD | MEDLEY PHARMACEUTICALS LTD | Formation of Black/Brown smudges inside the liquid |
| 24 | 12/10/2020 | Norotraz 12.5% 40ml | 8265-501NKL, 8494-501NKL, 9133-501NKL | NORBROOK (U) LTD | NORBROOK KENYA LTD | Crytallization of liquid |
| 25 | 12/14/2020 | FLUPHENAZINE DECANOATE INJECTION USP 25MG/ML | 70327 | GITTOES PHARMACEUTICALS LTD | ROTEX MEDICA GMBH ARZENEIMITTELWERK | Stability study failure showing out of Specification (OSS) for the impurity-free Fluphenazine content |
| 26 | 12/14/2020 | Lidocaine injection 2% | GM804, GM805, GM809 | GITTOES PHARMACEUTICALS LTD | UMEDICA LABORATORIES PVT LTD-PLOT NO. 221, 2ND PHASE, GIDC, VAPI 396195, GUJARAT. INDIA. | Adverse drug reactions due to use of the product |
| 27 | 12/17/2020 | Unibrol | 5806675 & 5806897 | DELMAW ENTERPRISES LTD | Universal Corporation Ltd - Kenya | Color change of tablets from white to Yellow |
| S/N | Date Initiated | Brand Name | Batch Number/s | LTR | Manufacturer | Reason / Problem |
|---|---|---|---|---|---|---|
| 1 | 02/04/2019 | Ciproren | 3718 | Rene Industries Ltd | RENE INDUSTRIES LTD | Failure to comply with BP specifications for dissolution tests |
| 2 | 02/04/2019 | Ciproleb | T2817 & T1877 | ANDYCO PHARMACY (U) LTD | LEBEN LABORATORIES Pvt | Failure to comply with BP specifications for dissolution tests |
| 3 | 04/04/2019 | Sypertix 10% EC | 8384-515NKL | NORBROOK (U) LTD | NORBROOK KENYA LTD | Failure to comply with CIPAC/WHOPES specifications for tests done for assay |
| 4 | 24/05/2019 | Albevet | 170724 | Global Vet (U) Ltd | The Arab pesticides and Veterinary Drugs Mfg. Co. Ltd | Failure to comply with USP specifications for Assay tests |
| 5 | 13/06/2019 | Aspirin delayed release 75mg | ET-1918035 | NATIONAL MEDICAL STORES | Flagship Biotec Int. Vadodara India | Lumping of tablets with a pungent smell |
| 6 | 11/07/2019 | 170428 | Albendastar 10% | NILE SERVICES LTD | Chongquing Factong Animal Pharmaceuticals Co. Ltd | Failure to comply with specifications for assay tests |
| 7 | 11/07/2019 | 0014 | Erazole 2.5 | ERAM (U) LTD | HEBEI YUANZHENG PHARMACEUTICALS COMPANY | Failure to comply with specifications for assay tests |
| 8 | 29/07/2019 | QK70373, QK70374, QK70375, QK70504, QK70505, QK70506, QK70515, QK70516, QK71004, QK80522, QK81415 | Texavir | QUALITY CHEMICALS LTD | CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED | Failure to comply with specifications for limits of unknown impurity |
| 9 | 14/08/2019 | EM83127B | Atazor-R | HARLEY'S (U) LTD | Emcure pharmaceuticals Ltd | Failure to comply with specifications for limits for hydroxy Ritonavir impurity |
| 10 | 19/08/2019 | LDC 180182 | Dolutegravir as Sodium | Cipla Quality Chemicals | Cipla Kurkumbh India | Failure to comply with specifications for limits for lead metal impurity |
| 11 | 18/09/2019 | Wormita | ERAM (U) LTD | Cosmos Ltd - Kenya | Failure to comply with specifications for pH tests | |
| 12 | 24/09/2019 | Agovir | GITTOES PHARMACEUTICALS LTD | Agog Pharma Ltd | Failure to comply with BP specifications for dissolution | |
| 13 | 14/10/2019 | All products suspended | VITACARE LTD | GRAND PHARMACEUTICAL (CHINA) CO LIMITED | Non compliance with GMP as per NDA Guidelines | |
| 14 | 29/10/2019 | Hydrogen Peroxide Mouthwash | Kwality AfroAsia Ltd | KWALITY AFROASIA LTD. | Failed to comply with specifications for Assay tests | |
| 15 | 30/10/2019 | Life guard | MARIE STOPES PHARMACY | MHL Health Care Ltd - India | Failed to comply with specifications for absence of holes and bust strength | |
| 16 | 31/10/2019 | Ashiaben 2.5% | MTK UGANDA LTD | ASHISH LIFE SCIENCES PVT LTD | Failure to comply with specifications for pH tests | |
| 17 | 11/11/2019 | ALL products suspended | ASTRA PHARMA (U) LTD | Zhejiang Ruixin Pharmaceutical Co. Ltd | not complying with GMP requiremnets as per NDA guidelines | |
| 18 | 25/11/2019 | Dabendazole | SUPER MEDIC LTD | MEDISEL KENYA LIMITED | Failure to comply with specifications for Assay and pH | |
| 19 | 19/12/2019 | Olfen 100 Decap | GOODMAN INTERNATIONAL LTD | ACINO PHARMA AG | OOS results for dissolution tests during stability testing |
