Rwanda Food and Drugs Authority
Public Product Recalls Register
QMS No: DIS/FMT/105
Revision No: 0
Effective Date: 07/10/2021
Ref. Doc.: DIS/GDL/034
Published recalls only. Click View for full details and recall letter.
| SN | File / Recall No. | Medicine Name | Manufacturer | Batch No. | Recall Level | Class | Safety Issue | Reporter | Date of Recall | Details |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DD/PVCT/1164/FDA/2025 |
Aspirine vitammin C 330MG/200 mg BN: B6224, Exp. 08/2026
|
UPSA SAS, France
|
B6224 | Consumer | Class II |
Color change from white to brown color
|
PHARMACURE PHARMACY | 23/04/2025 | |
| 2 | Ref No 011/RMS/CEO/2025 |
Chlorpheniramine (Chaleate) 4 mg tablets BN: 84936 exp. 10/ 2026
|
Lab & Allied Ltd, Kenya
|
84936 | Retail | Class II |
the product failed to comply with uniformity of content and assay test specifications.
|
RMS HQ | 27/01/2025 | |
| 3 | Ref:No 011/RMS/CEO/2025 |
Captopril 12.5 mg tablets USP BN 85181
|
Lab & Allied Ltd, Kenya
|
— | — |
failed dissolution rate test, uniformity of content
|
RMS HQ | 03/01/2025 | ||
| 4 | Ref No 009/RMS/CEO/2025 |
Omiren (Omeprazole Capsules BP 20 mg) BN: 00124 exp. 3/2026
|
RENE INDUSTRIES LTD, Kampala/ Uganda
|
— | — |
failed to comply with dissolution test specifications
|
RMS HQ | 03/01/2025 | ||
| 5 | Ref No 007/RMS/CEO/2025 |
Dix (Digoxin Tablets 0.25 mg) BN: T36028 exp. in 10/2026
|
Agog Pharma Ltd
|
T36028 | Retail | Class II |
the product failed to comply with uniformity of content and assay (overdosed) test specifications
|
RMS HQ | 03/01/2025 | |
| 6 | Ref.No:DD/PVCT/4564/FDA/2024 |
Efferalgan Vitamine C BN: A6091
|
UPSA SAS, France
|
— | — |
Color change from white to brown color
|
Bajaphar pharmacy, Vine Pharmacy, Pharmacure Pharmacy | 10/10/2024 | ||
| 7 | DD/PVCT/3853/FDA/2024 |
Methyldopa 250 mg tablets BN: 211371, 211372, and 211373
|
Sevatto Pharma 303, Gujarat, India
|
— | — |
Physical appearance ( Change of color)
|
CHUB, GIHUNDWE DH, KIBIRIZI DH, KIGEME DH, MUHIMA DH, RWAMAGANA DH | 02/09/2024 | ||
| 8 | Ref No.:FDISM/PVSM/5429/FDA/2023 |
Fluconazole 200mg tablets, BN: 5810315, Exp: 31/01/2025
|
Universal Corporation Ltd/ Kikuyu
|
5810315 | Retail | Class II |
The pink tablets displayed white discloration
|
Universal Corporation Ltd/ Kikuyu | 29/12/2023 | |
| 9 | Ref No.:FDISM/PVSM/5429/FDA/2023 |
Fluconazole 200mg tablets BN: 5810316, Exp: 31/01/2025
|
Universal Corporation Ltd/ Kikuyu
|
5810316 | Retail | Class II |
The pink tablets displayed white discloration
|
Universal Corporation Ltd/ Kikuyu | 29/12/2023 | |
| 10 | Ref No.:FDISM/PVSM/5429/FDA/2023 |
Fluconazole 200mg tablets BN: 5811390, Exp: 31/08/2025
|
Universal Corporation Ltd/ Kikuyu
|
5811390 | Retail | Class II |
The pink tablets displayed white discloration
|
Universal Corporation Ltd/ Kikuyu | 29/12/2023 | |
| 11 | Ref No.:FDISM/PVSM/5429/FDA/2023 |
Fluconazole 200mg tablets BN: 5810022, Exp: 31/08/2025
|
Universal Corporation Ltd/ Kikuyu
|
5810022 | Retail | Class II |
The pink tablets displayed white discloration
|
Universal Corporation Ltd/ Kikuyu | 29/12/2023 | |
| 12 | Ref.No.: FDISM/PVSM/3928/FDA/2023 |
Amoxiclav denk 1000/125mg powder for oral suspension BN:27296, Exp: 06/2025
|
PenCef Pharma GmbH/ Berlin
|
— | Retail | Class II |
Ongoing stability study and associated investigation indicated "change in appearance of individual sachets of AmoxiClav-Denk 1000/125 mg powder resulting in deviation of clavulanic acid content
|
18/09/2023 | ||
| 13 | Ref.No.: FDISM/PVSM/3928/FDA/2023 |
Amoxiclav denk 1000/125mg powder for oral suspension BN: 27297, Exp: 06/2025
|
PenCef Pharma GmbH/ Berlin
|
— | Retail | Class II |
Ongoing stability study and associated investigation indicated "change in appearance of individual sachets of AmoxiClav-Denk 1000/125 mg powder resulting in deviation of clavulanic acid content
|
18/09/2023 | ||
| 14 | Ref.No.: FDISM/PVSM/3928/FDA/2023 |
Amoxiclav denk 1000/125mg powder for oral suspension BN: 27298, Exp: 06/2025
|
PenCef Pharma GmbH/ Berlin
|
— | Retail | Class II |
Ongoing stability study and associated investigation indicated "change in appearance of individual sachets of AmoxiClav-Denk 1000/125 mg powder resulting in deviation of clavulanic acid content
|
18/09/2023 | ||
| 15 | Ref No.:FDISM/PVSM/2326/FDA/2023 |
Gastro-resistant sodium valproate tablets BP 300mg BN: All Exp. All
|
4 Care Lifescience Pvt Ltd/ India
|
— | Retail | Class II |
The tablets become sami-solid and cracked
|
Kirehe, Nyanza,Shyira,Mugonero,rwinkwavu, Gisenyi Hospitals | 30/05/2023 | |
| 16 | Ref No.:FDISM/PVSM/2326/FDA/2023 |
Gastro-resistant sodium valproate tablets BP 500mg BN: All Exp. All
|
4 Care Lifescience Pvt Ltd/ India
|
— | Retail | Class II |
The tablets become sami-solid and cracked
|
Kirehe, Nyanza,Shyira,Mugonero,rwinkwavu, Gisenyi Hospitals | 30/05/2023 | |
| 17 | Ref No.:FDISM/PVSM/419/FDA/2023 |
Spamox oral suspension (amoxicillin 125 mg/ 5ml) BN: All Exp. All
|
Sparsh Bio- Tech Pvt Ltd/ India
|
— | Retail | Class II |
Clumping of the powder for suspension
|
Murunda Hospital | 27/01/2023 | |
| 18 | Ref No.:FDISM/PVSM/419/FDA/2023 |
Spamox oral suspension (amoxicillin 250 mg/ 5ml) BN: All Exp. All
|
Sparsh Bio- Tech Pvt Ltd/ India
|
— | Retail | Class II |
Clumping of the powder for suspension
|
RMS Ltd | 27/01/2023 | |
| 19 | Ref No.:FDISM/PVSM/251/FDA/2023 |
Hyoscine Butylbromide tablets BP 10mg, BN: 22HB01, Exp. 03/2025
|
Morkash Pharmaceuticals Pvt Ltd/ India
|
— | Retail | Class II |
Presence of cracks on the surface of tablets
|
RMS Ltd | 18/01/2023 | |
| 20 | Ref No.:FDISM/PVSM/251/FDA/2023 |
Aminophylline tablets 100 MG USP, BN: 22AP01, Exp.03/2025
|
Morkash Pharmaceuticals Pvt Ltd/ India
|
— | Retail | Class II |
Presence of mottling on the surface of tablet
|
RMS Ltd | 18/01/2023 | |
| 21 | Ref.No.:FDISM/PVSM/3611/FDA/2022 |
Broncalene sp Adultes BN: All
|
MELISANA PHARMA
|
— | Consumer | Class I |
Increased risk of anaphylactic reaction on curares products used during general anesthesia
|
Melisana pharma | 16/09/2022 | |
| 22 | Ref No.:FDISM/PVSM/3611/FDA/2022 |
Broncalene sp Enfants BN: All
|
MELISANA PHARMA
|
— | Consumer | Class I |
Increased risk of anaphylactic reaction on curares products used during general anesthesia
|
Melisana pharma | 16/09/2022 | |
| 23 | Ref No.: DIS/1987/FDA/2022 |
Metronidazole Vaginal Tablets 500mg BN:T15039; 08/2024
|
Agog Pharma Ltd., India
|
— | Retail | Class II |
Presence of mottling on the surface of vaginal tablet
|
RMS Ltd | 29/04/2022 | |
| 24 | Ref No.: DIS/1987/FDA/2022 |
Amoxicillin oral Suspension BN: X0908 Exp. 11/2022
|
SPARSH BIO-TECH PVT Ltd/ INDIA
|
— | Retail | Class II |
Clumping of the powder for suspension
|
RMS Ltd | 29/04/2022 | |
| 25 | Ref No.: DIS/1987/FDA/2022 |
Amoxicillin oral Suspension BN: X0934 Exp. 05/2023
|
SPARSH BIO-TECH PVT Ltd/ INDIA
|
— | Retail | Class II |
Clumping of the powder for suspension
|
RMS Ltd | 29/04/2022 | |
| 26 | Ref No.: DIS/1987/FDA/2022 |
Amoxicillin oral Suspension BN: X0937 Exp. 05/2023
|
SPARSH BIO-TECH PVT Ltd/ INDIA
|
— | Retail | Class II |
Clumping of the powder for suspension
|
RMS Ltd | 29/04/2022 | |
| 27 | Ref No.: DIS/1987/FDA/2022 |
Amoxicillin oral Suspension BN: X0938 Exp. 05/2023
|
SPARSH BIO-TECH PVT Ltd/ INDIA
|
— | Retail | Class II |
Clumping of the powder for suspension
|
RMS Ltd | 29/04/2022 | |
| 28 | Ref No.: DIS/1987/FDA/2022 |
Amoxicillin oral Suspension BN: X0939 Exp. 05/2023
|
SPARSH BIO-TECH PVT Ltd/ INDIA
|
— | Retail | Class II |
Clumping of the powder for suspension
|
RMS Ltd | 29/04/2022 | |
| 29 | Ref No.: DIS/1987/FDA/2022 |
Amoxicillin oral Suspension BN: X0940 Exp. 05/2023
|
SPARSH BIO-TECH PVT Ltd/ INDIA
|
— | Retail | Class II |
Clumping of the powder for suspension
|
RMS Ltd | 29/04/2022 | |
| 30 | Ref No.: DIS/1987/FDA/2022 |
Amoxicillin oral Suspension BN: X0941 Exp. 05/2023
|
SPARSH BIO-TECH PVT Ltd/ INDIA
|
— | Retail | Class II |
Clumping of the powder for suspension
|
RMS Ltd | 29/04/2022 | |
| 31 | Ref No.: DIS/1987/FDA/2022 |
Amoxicillin oral Suspension BN: X0942 Exp. 05/2023
|
SPARSH BIO-TECH PVT Ltd/ INDIA
|
— | Retail | Class II |
Clumping of the powder for suspension
|
RMS Ltd | 29/04/2022 | |
| 32 | Ref No.: DIS/5050/FDA/2021 |
ALBAMAS-400 (Albendazole tablets 400mg) MTE20007
|
Mascot Health Series Pvt. Ltd, Plot No. 78,80,Sec-6A, IIE, Sidcul, Haridwar-249403, Uttarakhand, India
|
— | Retail | Class II |
change of tablet colour and most of tablets crumble upon unpacking from blisters
|
Escort Pharma Ltd | 10/12/2021 | |
| 33 | DIS/046/FDA/2021 |
Aminosidine 250mg(Unibrol) BN:5806898 Mfd:09/2019,Exp date:08/2022
|
Universal corporation/Kenya
|
— | Retail | Class II |
Color change for some tablet within blisters
|
IREME Pharmacy | 01/12/2021 | |
| 34 | DIS/046/FDA/2021 |
Aminosidine 250mg(Unibrol) BN:5806675 Mfd:06/2019,Exp date:05/2022
|
Universal corporation/Kenya
|
— | Retail | Class II |
Color change for some tablet within blisters
|
Client himself | 01/12/2021 | |
| 35 | Ref No.: DIS/3261/FDA/2021 |
Losar-Denk 25 mg film Coated ALL BATCHES
|
DENK PHARMA
|
— | Consumer | Class I |
Genotoxic impurity detected in API
|
DENK PHARMA | 07/10/2021 | |
| 36 | Ref No.: DIS/3261/FDA/2021 |
Losar-Denk 50 mg film Coated ALL BATCHES
|
DENK PHARMA
|
— | Consumer | Class I |
Genotoxic impurity detected in API
|
DENK PHARMA | 07/10/2021 | |
| 37 | Ref No.: DIS/3261/FDA/2021 |
Losar-Denk 100 mg film Coated ALL BATCHES
|
DENK PHARMA
|
— | Consumer | Class I |
Genotoxic impurity detected in API
|
DENK PHARMA | 07/10/2021 | |
| 38 | Ref No.: DIS/3261/FDA/2021 |
Colosar-Denk 50mg /12,5mg film coated tablet ALL BATCHES
|
DENK PHARMA
|
— | Consumer | Class I |
Genotoxic impurity detected in API
|
DENK PHARMA | 07/10/2021 | |
| 39 | Ref No.: DIS/3261/FDA/2021 |
Colosar-Denk 100 mg /12,5mg film coated tablet ALL BATCHES
|
DENK PHARMA
|
— | Consumer | Class I |
Genotoxic impurity detected in API
|
DENK PHARMA | 07/10/2021 | |
| 40 | DIS/1853/FDA/2021 |
Phytomenadione Inj. BP 10mg/ml BN:SA20C008E,Mfd:03/2020,Exp:02/2022
|
SANJAR PHARMA LLP,Himatnagar-
VijapurHighway,Dedhrota,Hitmatnagar-383 220, GUJARAT,INDIA
|
— | Retail | Class I |
Presence of Particulate matters in Vials
|
RMS Ltd | 25/05/2021 | |
| 41 | DIS/1853/FDA/2021 |
Hyoscine Butylbromide Injection BP 20mg/ml,BN:3H20001,Mfd:07/2020,Exp:06/2022
|
Centurion Healthcare Private Limited/601,
Atlantis Heights, Sarabhai Compound, Vadi Wadi,Vadodara-390 007, Gujarat,INDIA
|
— | Retail | Class I |
Presence of Particulate matters in Vials and Piece of broken glass in the ampoule
|
RMS Ltd | 25/05/2021 | |
| 42 | DIS/1853/FDA/2021 |
Hyoscine Butylbromide Injection BP 20mg/ml,3H20002,Mfd:08/2020,Exp:07/2022
|
Centurion Healthcare Private Limited
|
— | Retail | Class II |
Particulate matter
|
RMS Ltd | 25/05/2021 | |
| 43 | DIS/1853/FDA/2021 |
Furosemide injection 20mg/2ml,BN:JFDIE-001,Mfd:11/2019,Exp:10/2022
|
Laborate Pharmaceuticals India
|
— | Retail | Class I |
Presence of Particulate matters
|
RMS Ltd | 25/05/2021 | |
| 44 | DIS/1853/FDA/2021 |
Atropine injection,BN:16222001,Mfd:05/2020,Exp date:04/2023
|
Pharmax India Pvt.Ltd/India
|
— | Retail | Class I |
Presence of Particulate matters
|
RMS Ltd | 25/05/2021 | |
| 45 | DIS/1851/FDA/2021 |
Amoxicillin 250mg capsule BN:MP18485A,Mfd:-,Exp:09/2021
|
MILAN LABORATORIES (INDIA) PVT. LTD
|
— | Retail | Class II |
Presence of unidentified solid dark blue / black particles looking like foreign
impurities that contaminated the formulation during production
|
RMS Ltd | 25/05/2021 | |
| 46 | DIS/1857/FDA/2021 |
Azithromycin dry powder for suspension (ZEROCIN ) BN:75363,Mfd:09/2019,Exp:08/2021
|
Laboratory&Allied Ltd./kenya
|
— | Retail | Class II |
Caking of the powder in the bottom of the bottles causing poor flowability
|
Escort Pharma Ltd | 25/05/2021 | |
| 47 | DIS/2100/FDA/2021 |
Nystatin oral suspension BP 100 000 IU/ml BN:2006004 , Mfd:06/2020, Exp:05/2022
|
DAWA Limited/ KENYA
|
— | Retail | Class II |
More than 10 bottles were found with a solid lower sediment which is very difficult to shake to the homogeneous status, and several bottles seem to have developed microbial growths that led to the cloudy/misty appearance in the bottles
|
RMS Ltd | 25/05/2021 | |
| 48 | DIS/1441/FDA/2021 |
Unibrol(Aminosidine)250mg,BN:5805934,Mfd:02/2019,Exp:01/2022
|
Universal corporation/Kenya
|
— | Retail | Class II |
Change of color for some tablet with yellow color instead of white color
|
Clients | 28/04/2021 | |
| 49 | DIS/1257/FDA/2021 |
Telmisartan 40mg BN:FF9016,Mfd:06/2019,Exp:05/2022
|
Galaxy Pharmaceuticals/India
|
— | Retail | Class II |
The tablet broken down easily
|
Mediasol Pharmacy | 14/04/2021 | |
| 50 | DIS/1256/FDA/2021 |
AGOMYCIN Suspension (Erythromycin Estolate Oral Suspension 125mg/5ml),BN:L96013,Mfd:11/2019,Exp:10/2022
|
Agog Pharma Limited, India
|
— | Retail | Class II |
Low level of Content of Erythromycin Estolate eq. to
Erythromycin,36.476mgl5m1. while normal range should be 112.50 - 143.75mg15m|,
|
RMS Ltd | 14/04/2021 | |
| 51 | Ref No.:DIS/046/FDA/2021 |
Aminosidine 250mg(Unibrol) BN:5806898 Mfd:01/09/2019,Exp date:31/08/2022
|
Universal corporation/Kenya
|
— | Retail | Class II |
Color change for some tablet within blisters
|
Aminadab Pharmacy/Musanze | 12/01/2021 | |
| 52 | Ref No.:DIS/046/FDA/2021 |
Unibrol(Aminosidine)250mg,BN:5805934,Mfd:02/2019,Exp:01/2022
|
Universal corporation/Kenya
|
— | Retail | Class II |
Change of color for some tablet with yellow color instead of white color
|
Clients | 12/01/2021 | |
| 53 | Ref No.:DIS/046/FDA/2021 |
Unibrol(Aminosidine)250mg,BN:5807242,Mfd:02/2020,Exp:01/2023
|
Universal corporation/Kenya
|
— | Retail | Class II |
Change of color for some tablet with yellow color instead of white color
|
Clients | 12/01/2021 | |
| 54 | DIS/1164/RwandaFDA/2020 |
Benzyl penicillin procaine+DHS BN:MI12-06,Mfd:01/2019,Exp:01/2021
|
PUSHKIN LABORATORY LLC/Russia
|
— | Retail | Class II |
Precipitation of the product with crystallization
|
Rwanda FDA inspection | 06/12/2020 | |
| 55 | DIS/1164/RwandaFDA/2020 |
Benzyl penicillin procaine+DHS BN:MI12-07,Mfd:01/2019,Exp:06/2022
|
PUSHKIN LABORATORY LLC/Russia
|
— | Retail | Class II |
Precipitation of the product with crystallization
|
Rwanda FDA inspection | 06/12/2020 | |
| 56 | DIS/1164/RwandaFDA/2020 |
Benzyl penicillin procaine+DHS BN:MI12-08,Mfd:01/2019,Exp:01/2021
|
PUSHKIN LABORATORY LLC/Russia
|
— | Retail | Class II |
Precipitation of the product with crystallization
|
Rwanda FDA inspection | 06/12/2020 | |
| 57 | DIS/1164/RwandaFDA/2020 |
Benzyl penicillin procaine+DHS BN:MI12-09,Mfd:01/2019,Exp:01/2021
|
PUSHKIN LABORATORY LLC/Russia
|
— | Retail | Class II |
Precipitation of the product with crystallization
|
Rwanda FDA inspection | 06/12/2020 | |
| 58 | DIS/1164/RwandaFDA/2020 |
Benzyl penicillin procaine+DHS BN:MI12-10,Mfd:02/2019,Exp:02/2021
|
PUSHKIN LABORATORY LLC/Russia
|
— | Retail | Class II |
Precipitation of the product with crystallization
|
Rwanda FDA inspection | 06/12/2020 | |
| 59 | DIS/1164/RwandaFDA/2020 |
Benzyl penicillin procaine+DHS BN:MI12-11,Mfd:02/2019,Exp:02/2021
|
PUSHKIN LABORATORY LLC/Russia
|
— | Retail | Class II |
Precipitation of the product with crystallization
|
Rwanda FDA inspection | 06/12/2020 | |
| 60 | DIS/1164/RwandaFDA/2020 |
Benzyl penicillin procaine+DHS BN:MI12-12,Mfd:03/2019,Exp:03/2021
|
PUSHKIN LABORATORY LLC/Russia
|
— | Retail | Class II |
Precipitation of the product with crystallization
|
Rwanda FDA inspection | 06/12/2020 | |
| 61 | Ref.No.: DIS/2887/FDA/2020 |
Unibrol(Aminosidine)250mg,BN:586898,Mfd:09/2019,Exp:08/2022
|
Universal corporation/Kenya
|
— | Retail | Class II |
Color change for some tablet within blisters
|
AMAYA PHARMACY | 29/11/2020 | |
| 62 | DIS/1153/RwandaFDA/2020 |
Huureka Disinfectant
|
KEWS CORPORATION/SOUTH KOREA
|
— | Retail | Class II |
Suspected poor quality product
|
06/11/2020 | ||
| 63 | Ref.No: DIS/2419/FDA/2020 |
NEMCHEM Terminal Hand Sanitizer(Ethanol based),BN:0076,Mfd:20/03/2020,Exp:20/03/2022
|
NEM CHEM INTERNATIONAL
|
— | Retail | Class II |
Alcohol content at low level
|
Rwanda FDA | 25/10/2020 | |
| 64 | Ref.No.:DIS/2385/FDA/2020 |
Pure Skin Stay Safe Hand Sanitizer (Ethanol based) BN:001,Mfd:May 2020,Exp:April 2022
|
Africana Buffalo Ltd/Kigali,Gasabo
|
— | Retail | Class II |
Alcohol content at low level
|
Rwanda FDA | 21/10/2020 | |
| 65 | DIS/1876/FDA/2020 |
Complex Multivitamine injection veterinary medicine (BN: 190813, EXP: 08/2022)
|
HebeiChengSheng Tang Animal Pharmaceuticals
Co Ltd
|
— | Retail | Class II |
Lack of storage condition on the labeling
|
Rwanda FDA inspection | 31/08/2020 | |
| 66 | DIS/1876/FDA/2020 |
Complex Multivitamine injection veterinary medicine (BN: 190917, EXP: 09/2022)
|
HebeiChengSheng Tang Animal Pharmaceuticals
Co Ltd
|
— | Retail | Class II |
Lack of storage condition on the labeling
|
Rwanda FDA inspection | 31/08/2020 | |
| 67 | DIS/1876/FDA/2020 |
Novalgine injection 50% (BN 180608 , EXP06/2021)
|
HebeiChengSheng Tang Animal Pharmaceuticals
Co Ltd
|
— | Retail | Class II |
Lack of storage condition on the labeling
|
Rwanda FDA inspection | 31/08/2020 | |
| 68 | DIS/1876/FDA/2020 |
Novalgine injection 50% (BN 190729A , EXP07/2022)
|
HebeiChengSheng Tang Animal Pharmaceuticals
Co Ltd
|
— | Retail | Class II |
Lack of storage condition on the labeling
|
Rwanda FDA inspection | 31/08/2020 | |
| 69 | DIS/1876/FDA/2020 |
Ivermectine injection 1% (BN:180617, EXP: 06/2021)
|
HebeiChengSheng Tang Animal Pharmaceuticals
Co Ltd
|
— | Retail | Class II |
Lack of storage condition on the labeling
|
Rwanda FDA inspection | 31/08/2020 | |
| 70 | DIS/1877/FDA/2020 |
(Acaricide)Amitraz 12,5% EC
|
HebeiChengSheng Tang Animal Pharmaceuticals
Co Ltd
|
— | Retail | Class II |
Lack of storage condition and evaporation of the products
|
Rwanda FDA inspection | 31/08/2020 | |
| 71 | DIS/1940/FDA/2020 |
Guard Hand Sanitizer 30ml Mfd:10/03/2020,10/03/2021
|
KVMS Co. Ltd,Tel: 250788851252
|
— | Retail | Class II |
Failure to meet the quality of standard
|
Rwanda FDA | 09/04/2020 | |
| 72 | DIS/1941/FDA/2020 |
Purell-Instant Hand Sanitizer (60ML)
|
BELLA LTD
|
— | Retail | Class II |
Failure to meet the quality of standard
|
Rwanda FDA | 09/04/2020 | |
| 73 | DIS/CRC/007/Rwanda FDA/ 2020 |
Ketoconazole (kenazole) cream USP 2% W/W BN: 1907205 , EXP. 06/2022
|
DAWA Limited/ KENYA
|
— | Retail | Class III |
Compromised seal integrity of packs and leakage of the cream
|
PRIMA PHARMACY | 04/04/2020 | |
| 74 | Ref.No. 495 /RwandaFDA/2020 |
Cloxacillin 250 mg capsules, B.N: 1831132401, Mfg date: 12/2018, Exp. Date: 12/2021
|
REYOUNG PHARMACEUTICAL.CO.LTD/CHINA
|
— | Retail | Class III |
Capsules were reported self-opening when they are going to be dispensed
|
Gitwe HC | 19/03/2020 | |
| 75 | Ref.No. 495 /RwandaFDA/2020 |
Cloxacillin BP 250 mg capsules, B.N: 183132400, Mfg date: 12/2018, Exp date: 12/2021
|
REYOUNG PHARMACEUTICAL.CO.LTD/CHINA
|
— | Retail | Class III |
Capsules were reported self-opening when they are going to be dispensed
|
RUHANGO DP | 19/03/2020 | |
| 76 | Ref No 494/RwandaFDA/2020 |
Amoxycillin BP 250 mg capsules, B.N: 767190217; Mfg date: 02/2019; Exp date: 02/2022
|
CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG CO.LTD ) / HEBEI /CHINA
|
— | Retail | Class III |
Capsules were reported self-opening when they are going to be dispensed
|
RUHANGO DP | 19/03/2020 | |
| 77 | Ref.No. 495 /RwandaFDA/2020 |
Cloxacillin BP 250 mg capsules, B.N: 183132399 , Mfg date: 12/2018, Exp date: 12/2021
|
REYOUNG PHARMACEUTICAL.CO.LTD/CHINA
|
— | Retail | Class III |
Capsules were reported self-opening when they are going to be dispensed
|
BURERA DP | 19/03/2020 | |
| 78 | Ref No 494/RwandaFDA/2020 |
Amoxicilline 250 mg capsules B.N 767190205, Mfg date: 02/2019, Exp date: 02/2022
|
CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG CO.LTD ) / HEBEI /CHINA
|
— | Retail | Class III |
The medicines were reported to self opening and powder leakage
|
D.P RUTSIRO | 19/03/2020 | |
| 79 | Ref No 494/RwandaFDA/2020 |
Amoxycillin BP 250 mg capsules (AMOXIMED)/1000 capsules, B.N: 767190207, mfg date:02/2019, exp date: 02/2022
|
CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG CO.LTD ) / HEBEI /CHINA
|
— | Retail | Class III |
The medicines were reported to self opening and powder leakage
|
LEMEDICAL | 19/03/2020 | |
| 80 | Ref No 494/RwandaFDA/2020 |
Amoxycillin BP 250 mg capsules (AMOXIMED)/1000 capsules, B.N: 767190208, mfg date:02/2019, exp date: 02/2023
|
CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG CO.LTD ) / HEBEI /CHINA
|
— | Retail | Class III |
The medicines were reported to self opening and powder leakage
|
LEMEDICAL | 19/03/2020 | |
| 81 | Ref No 494/RwandaFDA/2020 |
Amoxycillin BP 250 mg capsules (AMOXIMED)/1000 capsules, B.N: 767190216, mfg date:02/2019, exp date: 02/2024
|
CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG CO.LTD ) / HEBEI /CHINA
|
— | Retail | Class III |
The medicines were reported to self opening and powder leakage
|
LEMEDICAL | 19/03/2020 | |
| 82 | Ref No137/RwandaFDA/2020 |
Entamizole DS ( Diloxanide furoate/ metronidazole 500/400mg)
|
ABBOTT LAB/PAKISTAN
|
— | Retail | Class II |
batch number and expiry dates on blisters were different from the one on outer package
|
UNIPHARMA | 19/03/2020 | |
| 83 | ODG/CRC/002/RwandaFDA/2020 |
Hand Sanitizers Manufactured by Oxalis Ltd
|
Oxalis Ltd
|
— | Retail | Class II |
Failure to meet the quality of standard
|
Rwanda FDA inspection | 15/03/2020 | |
| 84 | ODG/CRC/006/RwandaFDA/2020 |
BEU Hand Sanitizers
|
Holly Trust Ltd/Kamonyi District
|
— | Retail | Class II |
Failure to meet the quality of standard
|
Rwanda FDA inspection | 04/03/2020 | |
| 85 | Ref. No 260 / RwandaFDA/ 2020 |
Azithromycine dry powder suspension(Zerocin),BN:74261,Mfd:04/2019,Exp date:03/2021
|
Laboratory&Allied Ltd./kenya
|
— | Retail | Class II |
Caking of the powder in the bottom of the bottles causing poor flowability
|
Found during investigation | 13/02/2020 | |
| 86 | Ref. No 260 / RwandaFDA/ 2020 |
Azithromycine dry powder suspension(Zerocin),BN:74346,Mfd:05/2019,Exp date:04/2021
|
Laboratory&Allied Ltd./kenya
|
— | Retail | Class II |
Caking of the powder in the bottom of the bottles causing poor flowability
|
Client using tweeter | 13/02/2020 | |
| 87 | DIS/2129/FDA/2020 |
Lime Fresh Hand Sanitizer and disinfectants
|
Lime Fresh Family Ltd
|
— | Retail | Class II |
The hand sanitiser do not contain Alcohol
|
Rwanda FDA | 10/02/2020 | |
| 88 | Ref No137/RwandaFDA/2020 |
Debridat 24mg/ml granules for oral suspension,250ml BN:3814,Exp.date:06/2020
|
FARMEA10,RUE BOUCHE THOMAS
ZAC SUD D'ORGEMONT 49000 Angers
|
— | Retail | Class I |
Potential foreign materials in the products
|
Marketing authorisation Holder Pfizer | 29/01/2020 | |
| 89 | Ref No137/RwandaFDA/2020 |
Debridat 24mg/ml granules for oral suspension,250ml BN:3815,Exp.date:06/2020
|
FARMEA10,RUE BOUCHE THOMAS
ZAC SUD D'ORGEMONT 49000 Angers
|
— | Retail | Class I |
Potential foreign materials in the products
|
Marketing authorisation Holder Pfizer | 29/01/2020 | |
| 90 | Ref No137/RwandaFDA/2020 |
Debridat 24mg/ml granules for oral suspension,250ml BN:3816,Exp.date:06/2020
|
FARMEA10,RUE BOUCHE THOMAS
ZAC SUD D'ORGEMONT 49000 Angers
|
— | Retail | Class I |
Potential foreign materials in the products
|
Marketing authorisation Holder Pfizer | 29/01/2020 | |
| 91 | Ref No137/RwandaFDA/2020 |
Debridat 24mg/ml granules for oral suspension,250ml BN:3817,Exp.date:06/2020
|
FARMEA10,RUE BOUCHE THOMAS
ZAC SUD D'ORGEMONT 49000 Angers
|
— | Retail | Class I |
Potential foreign materials in the products
|
Marketing authorisation Holder Pfizer | 29/01/2020 | |
| 92 | Ref No137/RwandaFDA/2020 |
Debridat 24mg/ml granules for oral suspension,250ml BN:3818,Exp.date:06/2020
|
FARMEA10,RUE BOUCHE THOMAS
ZAC SUD D'ORGEMONT 49000 Angers
|
— | Retail | Class I |
Potential foreign materials in the products
|
Marketing authorisation Holder Pfizer | 29/01/2020 | |
| 93 | Ref No137/RwandaFDA/2020 |
Debridat 24mg/ml granules for oral suspension,250ml BN:3819,Exp.date:06/2020
|
FARMEA10,RUE BOUCHE THOMAS
ZAC SUD D'ORGEMONT 49000 Angers
|
— | Retail | Class I |
Potential foreign materials in the products
|
Marketing authorisation Holder Pfizer | 29/01/2020 | |
| 94 | Ref No137/RwandaFDA/2020 |
Debridat 24mg/ml granules for oral suspension,250ml BN:3820,Exp.date:06/2020
|
FARMEA10,RUE BOUCHE THOMAS
ZAC SUD D'ORGEMONT 49000 Angers
|
— | Retail | Class I |
Potential foreign materials in the products
|
Marketing authorisation Holder Pfizer | 29/01/2020 | |
| 95 | Ref No137/RwandaFDA/2020 |
Debridat 24mg/ml granules for oral suspension,250ml BN:3851,Exp.date:10/2020
|
FARMEA10,RUE BOUCHE THOMAS
ZAC SUD D'ORGEMONT 49000 Angers
|
— | Retail | Class I |
Potential foreign materials in the products
|
Marketing authorisation Holder Pfizer | 29/01/2020 | |
| 96 | Ref No137/RwandaFDA/2020 |
Debridat 24mg/ml granules for oral suspension,250ml BN:3852,Exp.date:10/2020
|
FARMEA10,RUE BOUCHE THOMAS
ZAC SUD D'ORGEMONT 49000 Angers
|
— | Retail | Class I |
Potential foreign materials in the products
|
Marketing authorisation Holder Pfizer | 29/01/2020 | |
| 97 | Ref No137/RwandaFDA/2020 |
Debridat 24mg/ml granules for oral suspension,250ml BN:3853,Exp.date:10/2020
|
FARMEA10,RUE BOUCHE THOMAS
ZAC SUD D'ORGEMONT 49000 Angers
|
— | Retail | Class I |
Potential foreign materials in the products
|
Marketing authorisation Holder Pfizer | 29/01/2020 | |
| 98 | Ref No137/RwandaFDA/2020 |
Debridat 24mg/ml granules for oral suspension,250ml BN:3867,Exp.date:02/2021
|
FARMEA10,RUE BOUCHE THOMAS
ZAC SUD D'ORGEMONT 49000 Angers
|
— | Retail | Class I |
Potential foreign materials in the products
|
Marketing authorisation Holder Pfizer | 29/01/2020 | |
| 99 | Ref No137/RwandaFDA/2020 |
Debridat 4.8mg/ml granules for oral suspension,125ml BN:3856,Exp.date:11/2020
|
FARMEA10,RUE BOUCHE THOMAS
ZAC SUD D'ORGEMONT 49000 Angers
|
— | Retail | Class I |
Potential foreign materials in the products
|
Marketing authorisation Holder Pfizer | 29/01/2020 | |
| 100 | Ref No137/RwandaFDA/2020 |
Debridat 4.8mg/ml granules for oral suspension,125ml BN:3857,Exp.date:11/2020
|
FARMEA10,RUE BOUCHE THOMAS
ZAC SUD D'ORGEMONT 49000 Angers
|
— | Retail | Class I |
Potential foreign materials in the products
|
Marketing authorisation Holder Pfizer | 29/01/2020 | |
| 101 | Ref No137/RwandaFDA/2020 |
Debridat 4.8mg/ml granules for oral suspension,125ml BN:3858Exp.date:11/2020
|
FARMEA10,RUE BOUCHE THOMAS
ZAC SUD D'ORGEMONT 49000 Angers
|
— | Retail | Class I |
Potential foreign materials in the products
|
Marketing authorisation Holder Pfizer | 29/01/2020 | |
| 102 | Ref No137/RwandaFDA/2020 |
Debridat 4.8mg/ml granules for oral suspension,125ml BN:3859,Exp.date:12/2020
|
FARMEA10,RUE BOUCHE THOMAS
ZAC SUD D'ORGEMONT 49000 Angers
|
— | Retail | Class I |
Potential foreign materials in the products
|
Marketing authorisation Holder Pfizer | 29/01/2020 | |
| 103 | Ref No137/RwandaFDA/2020 |
Debridat 4.8mg/ml granules for oral suspension,125ml BN:3860,Exp.date:12/2020
|
FARMEA10,RUE BOUCHE THOMAS
ZAC SUD D'ORGEMONT 49000 Angers
|
— | Retail | Class I |
Potential foreign materials in the products
|
Marketing authorisation Holder Pfizer | 29/01/2020 | |
| 104 | DIS/1311/RwandaFDA/2020 |
Safe Hands Sanitizers-Instant Hand Sanitizer
|
KVM Co LTD
|
— | Retail | Class II |
Poor quality Suspect
|
Rwanda FDA inspection | 07/01/2020 | |
| 105 | ref No. 1756/Rwanda FDA/2019 |
Helicobacter Pyroli rapid tests, BN: HPB11308, EXP :03/2020
|
QINGDAO HIGHTOP BIOTECH CO. LT
|
— | Retail | Class I |
There were many false positif
|
KIBOGORA dh | 18/12/2019 | |
| 106 | Ref No 1756/ Rwanda FDA/2019 |
Helicobacter Pylori Antibody test strip,B.N HPB11303B, mfd date: HPB11303B, exp date: 03-2021
|
QINGDAO HIGHTOP BIOTECH CO.,LTD/CHINA
|
— | Retail | Class I |
The rapid test were giving false positive results
|
Ngarama hospital | 18/12/2019 | |
| 107 | Ref No.1539/Rwanda FDA/2019 |
Paracetamol suspension 120mg/5ml (Toto-moL®), B.N: 73718,mfg date: 02/2019, exp date: 01/2022
|
Laboratory&Allied Ltd./kenya
|
— | Retail | Class II |
The product was detected with particulate matter
|
Client | 20/11/2019 | |
| 108 | Ref No 1243/RwandaFDA/2019 |
Ranitidine ( all Brand ,all batches)
|
all
|
— | Retail | Class I |
contain nitrosamine impurity classified as probable human carcinogen
|
DENK PHARMA | 11/10/2019 | |
| 109 | Ref No. 1722/RwandaFDA/2019 |
Urinalysis reagents strips with 3Parameters,BN:UR35111906A,Exp date:06/2021
|
Not mentioned
|
— | Retail | Class II |
Manufacturing date,manufacturer's name and Manufacturer adress were not mentionned
|
District Pharmacies | 12/09/2019 | |
| 110 | Ref No. 1722/RwandaFDA/2019 |
Urinalysis reagents strips with 3Parameters,BN:UR105111906A,Exp date:06/2021
|
Not mentioned
|
— | Retail | Class II |
Manufacturing date,manufacturer's name and Manufacturer adress were not mentionned
|
District Pharmacies | 12/09/2019 | |
| 111 | Ref No 0879/RwandaFDA/2019 |
Envit 100 ml, B.N: EEV1807, Exp date: 07/2020
|
Vitindia Pharmaceuticals Ltd A-6/1 India
|
— | Retail | Class II |
The solution had issue of sedimentation
|
25/07/2019 | ||
| 112 | Ref No 0879/RwandaFDA/2019 |
Envit 100 ml, B.N: EEV1808, Exp date: 07/2020
|
Vitindia Pharmaceuticals Ltd A-6/1 India
|
— | Retail | Class II |
The solution had issue of sedimentation
|
25/07/2019 | ||
| 113 | Ref No 0879/RwandaFDA/2019 |
Envit 100 ml,B.N:EEV 1713,Exp date:10/2019
|
Vitindia Pharmaceuticals Ltd A-6/1 India
|
— | Retail | Class II |
The solution had issue of sedimentation
|
25/07/2019 | ||
| 114 | Ref.No.0638/Rwanda FDA/2019 |
Albendazole 400 mg Tablets BN: 370420, Exp date: 08/2022
|
GlaxoSmithKline South Africa (Pty) Ltd.
|
370420 | Retail | Class II |
The product failed to dissolution test in Lab Quality control tests
|
RBC/MPPD | 18/06/2019 | |
| 115 | Ref.No.0638/Rwanda FDA/2019 |
Silver Sulfadiazine Cream USP 1% (Agoburn), BN: K82001, Exp date: 02/2021
|
Agog Pharma Ltd., India
|
— | Retail | Class II |
Failed the Assay (82.2%) test in Lab Quality control tests
|
RBC/MPPD | 18/06/2019 | |
| 116 | Ref.No.0638/Rwanda FDA/2019 |
Biperiden.HCl Sterop Tablets 2 mg BN: 18B05 Exp date: 01/2023
|
Lab. STEROP NV, Belgium
|
— | Retail | Class I |
The medicine was found with higher rate of impurities in Laboratory quality control tests
|
RBC/MPPD | 18/06/2019 | |
| 117 | Ref.No.0638/Rwanda FDA/2019 |
Chloramphenicol 0.5% w/v Eye Drops B.P; BN: 131936, Exp date: 01/2021
|
Abacus Parenteral Drugs Ltd., Uganda
|
— | Retail | Class II |
Failed the Assay test (77.1%) and the degradation product content.
|
RBC/MPPD | 18/06/2019 | |
| 118 | Ref No/0310/Rwanda FDA/2019 |
Dexamethasone 4mg/ml BN: 180468, Mfg date: 04/2018, Exp date: 03/2021
|
JIANGXI XIERKANGTAI PHARMACETICAL CO. LTD/CHINA
|
— | Retail | Class II |
The route of administration was not mentioned
|
SUN Pharma/CHUB | 14/03/2019 | |
| 119 | Ref No.0162/Rwanda FDA /2019 |
Hydralazine 20mg/ml BN: SX-18275; Mfg date: 07/2018,EXP: 06/2020
|
SWISS PARANTERALS Ltd
|
— | Retail | Class II |
The manufacturer declared that they have failed to on-going stabilitity studies and urged the recall
|
PROLINE | 21/02/2019 | |
| 120 | Ref No.0162/Rwanda FDA /2019 |
Hydralazine 20mg/ml BN: SX-18287 ,Mfg date: 07/2018; EXP: 06/2020
|
SWISS PARANTERALS ltd
|
— | Retail | Class II |
the manufacturer declared that they have failed to on-going stabilitity studies and urged the recall
|
PROLINE | 21/02/2019 | |
| 121 | Ref. No 0108/ Rwandafda/2019 |
Cynomax (misoprostol 200ug) MAXTAR B.N: M8TAB1801 (Exp: 4/2020)
|
BIO-GENICS /India
|
— | Retail | Class I |
Suspected poor Quality (Assay at 40%)
|
Tubingen University/Germany/BIZIMANA Thomas | 13/02/2019 | |
| 122 | Ref. No 0108/ Rwandafda/2019 |
C-STOL (Misoprostol 200 ug) CORONA B.N: ERW-005, EXP: 2/2021
|
Remedies Pvt Ltd/India
|
— | Retail | Class I |
Suspected poor Quality (Assay at 40%)
|
Tubingen University/Germany/BIZIMANA Thomas | 13/02/2019 | |
| 123 |
ANIOS SPECIAL DJP SF 4X5L, B.N:A24104S
|
Laboratoires Anios
|
— | Retail | Class I |
The product was reported to be contaminated by a bacteria
|
KIPHARMA | — | ||
| 124 |
ANIOS SPECIAL DJP SF 4X5L, B.N:B14316S
|
Laboratoires Anios
|
— | Retail | Class I |
The product was reported to be contaminated by a bacteria
|
KIPHARMA | — |