1 | January 18, 2018 | Male Latex Black Studded Condoms | 17N0452 | Karex Industries SDN BHD | Afford/UHMG | Failure to comply with ISO 4074:2015/WHO 2010 specifications for airburst volume and pressure |
2 | January 29, 2018 | Masculan (Pink colored, ribbed & dotted) | 17A28 | M.P.I Pharmaceuticals GmbH, Germany | Gama Pharmaceuticals (U) ltd | Failure to comply with manufacturer's specifications for lubricant quality |
3 | January 31, 2018 | Pre-powdered Surgical gloves | ARP414 | Lars Medicare PVT Ltd | Royal Pharma 2011 Ltd | Failure to comply with ISO 10282, ASTM D3577 for freedom from holes. |
4 | January 31, 2018 | Medisafe (Pre-powdered surgical latex gloves) | ARP452, ARP454 & ARP455 | Lars Medicare PVT Ltd | Abacus Pharma (A) Ltd | Failure to comply with ISO 10282, ASTM D3577 fro freedom from holes test |
5 | February 12, 2018 | Masculan condoms (colored, non-colored, dotted, ribbed, flavoured) | 17E15, 16H30, TN28471, TN28472 | M.P.I Pharmaceuticals GmbH, Germany | Gama Pharmaceuticals (U) Ltd | Failure to comply with manufaturer's specifications for lubricant quality |
6 | February 12, 2018 | Rhinathiol 5% Sugar free syrup | 6K0491 & 6K0531 | NATTERMAN & CIE , COLOGNE , GERMANY | Laborex (U) Ltd | Presence of visible brownish particles in the solution |
7 | February 19, 2018 | Mesotrim | 00117, 00217 & 00317 | Lifeway Pharmaceuticals Ltd-Uganda | Lifeway Pharmaceuticals Ltd | Failure to comply with dissolution test per USP specifications |
8 | February 20, 2018 | Zepar | 124 | Shaigan Pharmaceuticals PVT Ltd | Healthcare (U) Ltd | Failure to comply with USP specifications for pH |
9 | February 22, 2018 | Albax | BX.05.17 | Medipharm industries Ltd-Uganda | Medipharm industries Ltd | Failure to comply with USP specifications for pH |
10 | February 22, 2018 | Pre-powdered latex surgical gloves | ARP415 | Lars Medicare PVt Ltd | Royal Pharma 2011 Ltd | Failure to comply with ISO 10282, ASTM D3577 for freedom of holes |
11 | February 22, 2018 | Medicare powdered latex surgical gloves | ARP438 | Lars medicare PVT Ltd | Medvin Phrma Ltd | Failure to comply with ISO 10282, ASTM D3577 for freedom from holes test |
12 | February 22, 2018 | Zepar | 125 | Shaigan Pharmaceuticals PVT Ltd | Healthcare (U) Ltd | Failure to comply with USP specifications for pH |
13 | February 22, 2018 | Armour (powdered latex surgical gloves) | ARP423 | ASMA Rubber products Ltd | Surgimed Uganda Ltd | Failure to comply with ISO 10283, ASTM D3577 for freedom from holes |
14 | February 22, 2018 | Pre-powdered Latex surgical gloves | ARP456 | Lars medicare PVT Ltd | Abacus Pharma (A) Ltd | Failure to comply with ISO 10282, ASTM D3577 for freedom of holes |
15 | February 23, 2018 | Masculan (pur superfime & frutti edition) | CR29581 & 16H34 | M.P.I Pharmaceuticals GmbH, Germany | Gama Pharmaceuticals (U) Ltd | Failure to comply with manufacturer's specifications for lubricant quality |
16 | February 26, 2018 | Non colored contoured condoms | 160323 | Dongkuk Vietnam co. Ltd | UHMG for Ministry of Helath | Failure to comply with ISO 4074:2015/WHO 2010 specifications for airburst volume and pressure |
17 | February 26, 2018 | Broche (Powdered & Nitrile) examination gloves | 12201703(medium), 12201703(large), 1221702(medium) & 12201702(large) | Malaysia | Precise Diagnostics & medical Supplies Ltd | Failure to comply with ISO 1119-1, ASTM D3578 for freedom from holes test |
18 | February 26, 2018 | Paracetamol tablets | 160551 | Zheijiang Ruixin Phamraceuticals Co. Ltd | Astra Pharma (U) Ltd | Failure to comply with BP specifications for Assay |
19 | March 5, 2018 | K-Albendazole | 016 | Kwality Afro-Asia Ltd | Kwality Afro-Asia Ltd | Failure to comply with USP specifications for Assay |
20 | March 6, 2018 | Derma-1 | NF 601 | Triveni Formulations Ltd | Super Medic Ltd | Failure to comply with BP specifications for Assay |
21 | March 7, 2018 | Needles on 2ml syringes | 20170109 & 20170820 | Anthui Tiankang Medical technology Co. Ltd | Maisha Medical supplies | Failure to comply with manufacturer's specifications for lubricant quality |
22 | March 19, 2018 | Hydrocortisone sodium succinate | 7000415 & 7000215 | Karnataka Antibiotics & Pharmaceuticals Ltd | Tata (U) Ltd | Failure to comply with USP specifications for appearance on reconstitution and pH |
23 | March 21, 2018 | Agomol | L73016 | Agog Pharma Ltd | Gittoes Pharmaceuticals Ltd | Failure to comply with BP specifications for Assay |
24 | March 21, 2018 | Derma-1 | NF 602 & NF 603 | Triveni Formulations Ltd | Super Medic Ltd | Failure to comply with BP specifications for Assay |
25 | April 3, 2018 | Masculan Gold Anatomic contoured male latex condoms | AP31221 | M.P.I Pharmaceuticals GmbH, Germany | Gama Pharmaceuticals Ltd | Failure to comply with manufacturer's specifications for lubricant quality |
26 | April 3, 2018 | Alzol - 400 | 03217 | Rene Industries Ltd | Rene Industries Ltd | Wrong information leaflet in the product which is misleading |
27 | April 11, 2018 | Nulife Latex surgical gloves | T01900 | MRK Healthcare PVT | Joint Medical Stores | Failure to comply with manufacturer's specifications/ISO 10282 for dimensions test. |
28 | April 24, 2018 | Revital Re-use syringes | 054117 & 054417 | Revital Healthcare (EPZ) Ltd | Abacus Pharma (A) Ltd | Parts of the plunger peel off into the contents of the syringe |
29 | April 24, 2018 | Hydralazine 20mg/ml | SX-17262 | Swiss Parenterals PVT Ltd | Shreeji Pharmaceuticals Ltd | Presence of growth and visible particulate matter in the product |
30 | May 18, 2018 | Gentamycin Injection | 171225 & 171226 | Zhejiang Ruixin Pharmaceuticals Co. Ltd | Astra Pharma (U) Ltd | Illegible and faint labels on the ampoules |
31 | May 18, 2018 | Sequozole | LQ/16047/01 & LQ/16050/01 | Alivira Animal helath Ltd | Eram Uganda | Illegible labels, and easily erased (dates of manufacturers and expiry dates) |
32 | May 22, 2018 | Gentamicin Injection | 170390 & 170929 | Anhui Chengshi Manufacture Medical Co. Ltd | RENE PHARMACY LTD | Immediate adverse events upon administered: Severe headache, dizziness, blurred vision, fainting in some patients, rash and itching. |
33 | May 28, 2018 | Vitamin B complex Injection | 171231 & 161223 | Zhejiang Ruixin Pharmaceuticals Co. Ltd | Astra Pharma (U) Ltd | Illegible and easily erased labels on the ampoules |
34 | May 30, 2018 | KAM-O Mint | KOT 16028, 16029 & 16034 | Kampala Pharmaceuticals Industries Ltd | Kampala Pharmaceuticals Industries Ltd | Failure to comply with specifications for hardness test. The tablets are very hard to chew. |
35 | May 31, 2018 | Bimatraz | B031117A | Bimeda Chemicals Export - Ireland | Bimeda (U) Ltd | Failure to comply with USP specifications for the Assay test |
36 | May 31, 2018 | Latex Surgical Gloves | 20160920 | Jiangsu Changzou Yihua Sanitation Material Co. Ltd - China | National Medical Stores | Failure to comply with ASTM D3577 specifications for freedom from holes test. |
37 | June 1, 2018 | Gentamicin Injection | 1703106 | SHANDONG XIER KANGTAI PHARMACEUTICALS COMPANY LTD | ABACUS PHARMA (A) LTD | Immediate adverse events upon administered: Severe headache, dizziness, blurred vision, fainting in some patients, rash and itching. |
38 | June 22, 2018 | Vitamin B complex | 171230 | Zhejiang Ruixin Pharmaceuticals Co. Ltd | Astra Pharma (U) Ltd | Failure to comply with labelling requirments for use of indelible Ink markings for product labels. |
39 | July 25, 2018 | Valsar Denk: 80, 160, 320 & Covalsar denk: 80/12.5, 160/12.5, 320/12.5 | All | Denk Pharma Gmbh & Co. kg | Benle Consults Ltd | Contamination with carcinogenic impurity called NMDA |
40 | July 31, 2018 | Valsar 80 & Valsar 160 | All Batches | Hetero Labs Ltd UNIT V | Abacus Pharma (U) Ltd | Contamination with carcinogenic impurity called (NMDA) |
41 | August 1, 2018 | Diclomax - 75 | 170409 | Jiangsu Pengyao Pharmaceutical Co. Ltd | Abacus Pharma (U) Ltd | Product changes color on storage and presence of visible particulate matter |
42 | August 13, 2018 | Diclomax - 75 | All | Jiangsu Pengyao Pharmaceutical Co. Ltd | ABACUS PHARMA (A) LTD | Poor quality |
43 | August 13, 2018 | Hydrocortisone Sodium Succinate | All Batches | Swiss Parenterals PVT ltd | Shreeji Pharmaceuticals Ltd | Continued failure to comply with quality specifications |
44 | August 16, 2018 | Furosemide injection BP 10mg/2ml | 180120 | Grand Pharmaceuticals Co. Ltd | Vitacare Pharmacy Ltd | Misleading information leaflet |
45 | August 16, 2018 | Ocucycline 1% | C971 | Centaur Pharmaceuticals PVT ltd | Gittoes Pharmaceuticals Ltd | Change in color from yellow to brown |
46 | August 23, 2018 | Agovir Tablets | T72074 | Agog Pharma Ltd | Gittoes Pharmaceuticals Ltd | Failure to comply with the dissolution test. |
47 | August 31, 2018 | Hydralazine 20mg/ml | SX-17262 and All batches | Swiss Parenterals PVT ltd | Shreeji Pharmaceuticals Ltd | Visible particulate matter in the injectable solution |
48 | September 13, 2018 | Diclofenac Injection | All batches | Jiangsu Pengyao Pharmaceutical Co. Ltd | Harley's Uganda Ltd | Discolaration of otherwise colorless solution and appearance of visible particulate matter in the ampoules |
49 | September 20, 2018 | Gentamycin Injection | All | Anhui Chengshi Manufacture Medical Co. Ltd | Rene Pharmaceuticals Ltd | Immediate adverse events upon administered: Severe headache, dizziness, blurred vision, fainting in some patients, rash and itching. |
50 | September 20, 2018 | Gmycin-80 | ALL | Jiangsu Pengyao Pharmaceutical Co. Ltd | Abacus Pharma (U) Ltd | Immediate adverse events upon administered: Severe headache, dizziness, blurred vision, fainting in some patients, rash and itching. |
51 | September 20, 2018 | Gentamycin Injection | All batches | Anhui Chengshi Manufacture Medical Co. Ltd | Rene Pharmaceuticals Ltd | Immediate adverse events upon administered: Severe headache, dizziness, blurred vision, fainting in some patients, rash and itching. |
52 | October 24, 2018 | R-ether, Gmycin-80, Falcimax-600, Artemether inj, Quinine dihydrochloride & Diclomax-75 | All | Jiangsu Pengyao Pharmaceutical Co. Ltd | Abacus Pharma (U) Ltd | Failure to comply with GMP specifications |
53 | October 24, 2018 | Celtriaxone, Expen & procilin | ALL | SHANDONG XIER KANGTAI PHARMACEUTICALS COMPANY LTD | Abacus Pharma (U) Ltd, Delmaw Limited, Royal Pharma 2011 Ltd & Super Pharmacy | Failure to comply with GMP specifications |
54 | October 24, 2018 | Gentamicin injection, Artemether inj, Vitamin B inj & Diclofenac sodium | ALL | Anhui Chengshi Manufacture Medical Co. Ltd | RENE PHARMACY LTD | Failure to comply with GMP specifications |
55 | October 24, 2018 | Agocal ablets | T61106 | Agog Pharma Ltd | Gittoes Pharmaceuticals Ltd | Discoloration of the product on storage |
56 | November 8, 2018 | Ibumol suspension | CK0238C | AJANTA PHARMA LTD | ABACUS PHARMA (A) LTD | Product forms cakes and plaques during storage |
57 | November 9, 2018 | M-energex coffee and M-energex capsules | 136868 & SE18J276 | Bio Gallery SDN | Dewyx International Company | Quality tests indicated that the product is adulterated with Tadalafil |
58 | December 12, 2018 | Gentamicin injection | ALL | GRAND PHARMACEUTICAL (CHINA) CO LIMITED | HARLEY'S (U) LTD | Immediate adverse events upon administered: Severe headache, dizziness, blurred vision, fainting in some patients, rash and itching. |