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 |
| 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 |
| 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 |
| 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 |
