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 | Quality/Safety Issue | Date of Recall | Details |
|---|---|---|---|---|---|---|---|---|---|
| 1 | AKER101/001-2026 |
Akerol 2.5mg/5ml sp F/60ml
|
WEST COAST PHARMACEUTICAL WORKS Ltd, India
|
ALL BATCHES | Retail | Class II |
Leakage of the syrup
|
24/04/2026 | |
| 2 | Ref. No.: DD/PVCT/0469/FDA/2026 |
Nexium® (Esomeprazole) 20 mg tablets All batches
|
AstraZeneca/Istanbul
|
ALL BATCHES | Retail | Class II |
The products were imported without a valid Rwanda FDA permit and are labeled in unofficial languages.
|
05/02/2026 | |
| 3 | Ref. No.: DD/PVCT/0469/FDA/2026 |
Nexium® (Esomeprazole) 40 mg tablets All batches
|
AstraZeneca/Istanbul
|
ALL BATCHES | Retail | Class II |
The products were imported without a valid Rwanda FDA permit and are labeled in unofficial languages.
|
05/02/2026 | |
| 4 | Ref. No.: DD/PVCT/0469/FDA/2026 |
Flagentyl® (Secnidazole )500 mg tablets All batches
|
Aventis Pharma S.A/Istanbul
|
ALL BATCHES | Retail | Class II |
The products were imported without a valid Rwanda FDA permit and are labeled in unofficial languages.
|
05/02/2026 | |
| 5 | Ref. No.: DD/PVCT/0469/FDA/2026 |
Imodium® (Loperamide hydrochloride) 2 mg capsules All batches
|
ASPIN Pharma PVT Ltd, Pakistan
|
ALL BATCHES | Retail | Class II |
The products were imported without a valid Rwanda FDA permit and are labeled in unofficial languages.
|
05/02/2026 | |
| 6 | PRINTIMATION101012025 |
Rosuvastatin tablet 20 mg ( rosumac)
|
Macleods Pharmaceuticals Limited
|
BN:14242086A | Retail | Class II |
An out-of-specification result observed during stability testing
|
25/10/2025 | |
| 7 | Ref.No.:DD/PVCT/3562/FDA/2025 |
Adhesive perforated plaster, all Batches manufactured by JINHUA JINGDI MEDICAL SUPPLIES Co. Ltd /China
|
JINHUA JINGDI MEDICAL SUPPLIES Co. Ltd /China
|
ALL BATCHES | Wholesale | Class II |
the plaster leaves color stains on patients’ linens and on the applied areas of the skin
|
24/09/2025 | |
| 8 | Ref.No.:DD/PVCT/3562/FDA/2025 |
IV Catheter G24, all batches manufactured by ANJI SPENQ INDUSTRIAL CO. LTD/China
|
ANJI SPENQ INDUSTRIAL CO. LTD/China
|
ALL BATCHES | Wholesale | Class II |
the catheter are easily broken and causes trauma to the patients during use
|
24/09/2025 | |
| 9 | Ref.No:DD/PVCT/2974/FDA/2025 |
PROSTREP 20/20 INJ 100ml (Procaine Benzyl Penicillin 200mg, Dihydrostreptomycin Sulphate 200mg)
|
ModHike Private Limited
|
BN:MV32-002 | Retail | Class II |
Precipitates in solution and color change from white to yellow
|
25/08/2025 | |
| 10 | Ref.No:DD/PVCT/2974/FDA/2025 |
PROSTREP 20/20 INJ 100ml (Procaine Benzyl Penicillin 200mg, Dihydrostreptomycin Sulphate 200mg)
|
ModHike Private Limited
|
BN:MV32-003 | Retail | Class II |
Precipitates in solution and color change from white to yellow
|
25/08/2025 | |
| 11 | Ref.No:DD/PVCT/2974/FDA/2025 |
PROSTREP 20/20 INJ 100ml (Procaine Benzyl Penicillin 200mg, Dihydrostreptomycin Sulphate 200mg)
|
ModHike Private Limited
|
BN:MV32-004 | Retail | Class II |
Precipitates in solution and color change from white to yellow
|
25/08/2025 | |
| 12 | Ref.No:DD/PVCT/2974/FDA/2025 |
PROSTREP 20/20 INJ 100ml (Procaine Benzyl Penicillin 200mg, Dihydrostreptomycin Sulphate 200mg)
|
ModHike Private Limited
|
BN:MV32-005 | Retail | Class II |
Precipitates in solution and color change from white to yellow
|
25/08/2025 | |
| 13 | Ref.No:DD/PVCT/2925/FDA/2025 |
Lidocaine 2% injection 30ml
|
Merit Organic Ltd (India)
|
BN:I02171 | Retail | Class II |
particulate matter within the solution for injection
|
20/08/2025 | |
| 14 | Ref: No 2260/RMS/CEO/2025 |
Lidocaine 2% injection 30ml
|
Merit Organic Ltd (India)
|
BN:I02158 | Retail | Class II |
particulate matter within the solution for injection
|
15/07/2025 | |
| 15 | Ref: No 2260/RMS/CEO/2025 |
Lidocaine 2% injection 30ml
|
Merit Organic Ltd (India)
|
BN: I02161 | Retail | Class II |
particulate matter within the solution for injection
|
15/07/2025 | |
| 16 | Ref: No 2260/RMS/CEO/2025 |
Lidocaine 2% injection 30ml
|
Merit Organic Ltd (India)
|
BN:I02163 | Retail | Class II |
particulate matter within the solution for injection
|
15/07/2025 | |
| 17 | Ref: No 2260/RMS/CEO/2025 |
Lidocaine 2% injection 30ml
|
Merit Organic Ltd (India)
|
BN:I02164 | Retail | Class II |
particulate matter within the solution for injection
|
15/07/2025 | |
| 18 | Ref: No 2260/RMS/CEO/2025 |
Lidocaine 2% injection 30ml
|
Merit Organic Ltd (India)
|
BN:I02165 | Retail | Class II |
particulate matter within the solution for injection
|
15/07/2025 | |
| 19 | Ref: No 2260/RMS/CEO/2025 |
Lidocaine 2% injection 30ml
|
Merit Organic Ltd (India)
|
BN:I02166 | Retail | Class II |
particulate matter within the solution for injection
|
15/07/2025 | |
| 20 | Ref: No 2260/RMS/CEO/2025 |
Lidocaine 2% injection 30ml
|
Merit Organic Ltd (India)
|
BN:I02172 | Retail | Class II |
particulate matter within the solution for injection
|
15/07/2025 | |
| 21 | Ref: No 2260/RMS/CEO/2025 |
Lidocaine 2% injection 30ml
|
Merit Organic Ltd (India)
|
BN:I02173 | Retail | Class II |
particulate matter within the solution for injection
|
15/07/2025 | |
| 22 | Ref: No 2260/RMS/CEO/2025 |
Lidocaine 2% injection 30ml
|
Merit Organic Ltd (India)
|
BN:I02174 | Retail | Class II |
particulate matter within the solution for injection
|
15/07/2025 | |
| 23 | Ref: No 2260/RMS/CEO/2025 |
Lidocaine 2% injection 30ml
|
Merit Organic Ltd (India)
|
BN:I02175 | Retail | Class II |
particulate matter within the solution for injection
|
15/07/2025 | |
| 24 | 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
|
23/04/2025 | |
| 25 | Ref No 011/RMS/CEO/2025 |
Chlorpheniramine (Chaleate) 4 mg tablets BN: 84936 exp. 10/ 2026
|
Lab & Allied Ltd, Kenya
|
BN: 84936 exp. 10/ 2026 | Retail | Class II |
the product failed to comply with uniformity of content and assay test specifications.
|
27/01/2025 | |
| 26 | Ref:No 011/RMS/CEO/2025 |
Captopril 12.5 mg tablets USP
|
Lab & Allied Ltd, Kenya
|
BN 85181 | Retail | Class II |
failed dissolution rate test, uniformity of content
|
03/01/2025 | |
| 27 | 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
|
03/01/2025 | |
| 28 | Ref.No:DD/PVCT/4564/FDA/2024 |
Efferalgan Vitamine C
|
UPSA SAS, France
|
BN: A6091 | Retail | Class II |
Color change from white to brown color
|
10/10/2024 | |
| 29 | DD/PVCT/3853/FDA/2024 |
Methyldopa 250 mg tablets
|
Sevatto Pharma 303, Gujarat, India
|
BN: 211371, 211372, and 211373 | Retail | Class II |
Physical appearance ( Change of color)
|
02/09/2024 | |
| 30 | Ref.No.:DD/PVCT/2986/FDA/2024 |
Efferalgan vitamine c 500mg/200mg
|
UPSA SAS, France
|
BN:A4042 | Consumer | Class II |
Color change from white to brown color
|
30/06/2024 | |
| 31 | Ref.No.:DD/PVCT/2985/FDA/2024 |
Tetracycline eye ointment
|
Curis Lifescience Pvt Ltd, India
|
BN:23038, | Consumer | Class II |
Discloration
|
30/06/2024 | |
| 32 | Ref. No.: DD/PVCT/2408/FDA/2024 |
Warfarin 1mg tablets
|
Angel Biogenics Pvt. Ltd, India
|
BN:T220237 | Retail | Class II |
does not meet quality standards with regards to uniformity of contents.
|
26/05/2024 | |
| 33 | Ref No.: FDISM/PVSM/1248/FDA/2024 |
Tetracycline eye ointment , All natches
|
Angel Biogenics Pvt Ltd
|
All batches | Consumer | Class II |
Discloration
|
11/03/2024 | |
| 34 | Ref.No.: FDISM/PVSM/1251/FDA/2024 |
Phytomenadione Inj. BP 10mg/ml ,BN:I13612, Mfg:Jan 2023, Dec 2025
|
Merit Organics Ltd
|
I13612 | Retail | Class II |
Variation in PH
|
11/03/2024 | |
| 35 | 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
|
29/12/2023 | |
| 36 | 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
|
29/12/2023 | |
| 37 | 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
|
29/12/2023 | |
| 38 | 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
|
29/12/2023 | |
| 39 | Ref.No.: FDISM/PVSM/3928/FDA/2023 |
Amoxiclav denk 1000/125mg powder for oral suspension
|
PenCef Pharma GmbH/ Berlin
|
BN:27296, Exp: 06/2025 | 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 | |
| 40 | Ref.No.: FDISM/PVSM/3928/FDA/2023 |
Amoxiclav denk 1000/125mg powder for oral suspension
|
PenCef Pharma GmbH/ Berlin
|
BN: 27297, Exp: 06/2025 | 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 | |
| 41 | Ref.No.: FDISM/PVSM/3928/FDA/2023 |
Amoxiclav denk 1000/125mg powder for oral suspension BN: 27298, Exp: 06/2025
|
PenCef Pharma GmbH/ Berlin
|
27298 | 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 | |
| 42 | Ref No.:FDISM/PVSM/2326/FDA/2023 |
Gastro-resistant sodium valproate tablets BP 300mg
|
4 Care Lifescience Pvt Ltd/ India
|
BN: All Exp. All | Retail | Class II |
The tablets become sami-solid and cracked
|
30/05/2023 | |
| 43 | Ref No.:FDISM/PVSM/2326/FDA/2023 |
Gastro-resistant sodium valproate tablets BP 500mg
|
4 Care Lifescience Pvt Ltd/ India
|
BN: All Exp. All | Retail | Class II |
The tablets become sami-solid and cracked
|
30/05/2023 | |
| 44 | Ref No.:FDISM/PVSM/419/FDA/2023 |
Spamox oral suspension (amoxicillin 125 mg/ 5ml)
|
Sparsh Bio- Tech Pvt Ltd/ India
|
BN: All Exp. All | Retail | Class II |
Clumping of the powder for suspension
|
27/01/2023 | |
| 45 | Ref No.:FDISM/PVSM/419/FDA/2023 |
Spamox oral suspension (amoxicillin 250 mg/ 5ml)
|
Sparsh Bio- Tech Pvt Ltd/ India
|
BN: All Exp. All | Retail | Class II |
Clumping of the powder for suspension
|
27/01/2023 | |
| 46 | Ref No.:FDISM/PVSM/417/FDA/FDA/2023 |
Gastro-resistant sodium valproate tablets BP 300mg
|
4 Care Lifescience Pvt Ltd/ India
|
BN: 4S08201 Exp. 01/2025 | Retail | Class II |
The tablets become sami-solid and cracked
|
27/01/2023 | |
| 47 | Ref No.:FDISM/PVSM/417/FDA/FDA/2023 |
Gastro-resistant sodium valproate tablets BP 500mg
|
4 Care Lifescience Pvt Ltd/ India
|
BN: 4S09201 Exp. 01/2025 | Retail | Class II |
The tablets become sami-solid and cracked
|
27/01/2023 | |
| 48 | Ref No.:FDISM/PVSM/251/FDA/2023 |
Hyoscine Butylbromide tablets BP 10mg,
|
Morkash Pharmaceuticals Pvt Ltd/ India
|
BN: 22HB01, Exp. 03/2025 | Retail | Class II |
Presence of cracks on the surface of tablets
|
18/01/2023 | |
| 49 | Ref No.:FDISM/PVSM/251/FDA/2023 |
Aminophylline tablets 100 MG USP,
|
Morkash Pharmaceuticals Pvt Ltd/ India
|
BN: 22AP01, Exp.03/2025 | Retail | Class II |
Presence of mottling on the surface of tablet
|
18/01/2023 | |
| 50 | Ref No.: DIS/1987/FDA/2022 |
Metronidazole Vaginal Tablets 500mg
|
Agog Pharma Ltd., India
|
BN:T15039; 08/2024 | Retail | Class II |
Presence of mottling on the surface of vaginal tablet
|
29/04/2022 | |
| 51 | Ref No.: DIS/1987/FDA/2022 |
Amoxicillin oral Suspension (SPAMOX)
|
SPARSH BIO-TECH PVT Ltd/ INDIA
|
BN: X0908 Exp. 11/2022 | Retail | Class II |
Clumping of the powder for suspension
|
29/04/2022 | |
| 52 | Ref No.: DIS/1987/FDA/2022 |
Amoxicillin oral Suspension (spamox)
|
SPARSH BIO-TECH PVT Ltd/ INDIA
|
BN: X0934 Exp. 05/2023 | Retail | Class II |
Clumping of the powder for suspension
|
29/04/2022 | |
| 53 | Ref No.: DIS/1987/FDA/2022 |
Amoxicillin oral Suspension
|
SPARSH BIO-TECH PVT Ltd/ INDIA
|
BN: X0937 Exp. 05/2023 | Retail | Class II |
Clumping of the powder for suspension
|
29/04/2022 | |
| 54 | Ref No.: DIS/1987/FDA/2022 |
Amoxicillin oral Suspension
|
SPARSH BIO-TECH PVT Ltd/ INDIA
|
BN: X0938 Exp. 05/2023 | Retail | Class II |
Clumping of the powder for suspension
|
29/04/2022 | |
| 55 | Ref No.: DIS/1987/FDA/2022 |
Amoxicillin oral Suspension
|
SPARSH BIO-TECH PVT Ltd/ INDIA
|
BN: X0939 Exp. 05/2023 | Retail | Class II |
Clumping of the powder for suspension
|
29/04/2022 | |
| 56 | Ref No.: DIS/1987/FDA/2022 |
Amoxicillin oral Suspension
|
SPARSH BIO-TECH PVT Ltd/ INDIA
|
BN: X0940 Exp. 05/2023 | Retail | Class II |
Clumping of the powder for suspension
|
29/04/2022 | |
| 57 | Ref No.: DIS/1987/FDA/2022 |
Amoxicillin oral Suspension
|
SPARSH BIO-TECH PVT Ltd/ INDIA
|
BN: X0941 Exp. 05/2023 | Retail | Class II |
Clumping of the powder for suspension
|
29/04/2022 | |
| 58 | Ref No.: DIS/1987/FDA/2022 |
Amoxicillin oral Suspension
|
SPARSH BIO-TECH PVT Ltd/ INDIA
|
BN: X0942 Exp. 05/2023 | Retail | Class II |
Clumping of the powder for suspension
|
29/04/2022 | |
| 59 | Ref No.: DIS/5050/FDA/2021 |
ALBAMAS-400 (Albendazole tablets 400mg)
|
Mascot Health Series Pvt. Ltd, Plot No. 78,80,Sec-6A, IIE, Sidcul, Haridwar-249403, Uttarakhand, India
|
MTE20007 | Retail | Class II |
change of tablet colour and most of tablets crumble upon unpacking from blisters
|
10/12/2021 | |
| 60 | DIS/046/FDA/2021 |
Aminosidine 250mg(Unibrol)
|
Universal corporation/Kenya
|
BN:5806898 Mfd:09/2019,Exp date:08/2022 | Retail | Class II |
Color change for some tablet within blisters
|
01/12/2021 | |
| 61 | DIS/046/FDA/2021 |
Aminosidine 250mg(Unibrol)
|
Universal corporation/Kenya
|
BN:5806675 Mfd:06/2019,Exp date:05/2022 | Retail | Class II |
Color change for some tablet within blisters
|
01/12/2021 | |
| 62 | DIS/1853/FDA/2021 |
Hyoscine Butylbromide Injection BP 20mg/ml,
|
Centurion Healthcare Private Limited
|
3H20002,Mfd:08/2020,Exp:07/2022 | Retail | Class II |
Particulate matter
|
25/05/2021 | |
| 63 | DIS/1851/FDA/2021 |
Amoxicillin 250mg capsule
|
MILAN LABORATORIES (INDIA) PVT. LTD
|
BN:MP18485A,Mfd:-,Exp:09/2021 | Retail | Class II |
Presence of unidentified solid dark blue / black particles looking like foreign
impurities that contaminated the formulation during production
|
25/05/2021 | |
| 64 | DIS/1857/FDA/2021 |
Azithromycin dry powder for suspension (ZEROCIN )
|
Laboratory&Allied Ltd./kenya
|
BN:75363,Mfd:09/2019,Exp:08/2021 | Retail | Class II |
Caking of the powder in the bottom of the bottles causing poor flowability
|
25/05/2021 | |
| 65 | DIS/2100/FDA/2021 |
Nystatin oral suspension BP 100 000 IU/ml
|
DAWA Limited/ KENYA
|
BN:2006004 , Mfd:06/2020, Exp:05/2022 | 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
|
25/05/2021 | |
| 66 | DIS/1441/FDA/2021 |
Unibrol(Aminosidine)250mg,
|
Universal corporation/Kenya
|
BN:5805934,Mfd:02/2019,Exp:01/2022 | Retail | Class II |
Change of color for some tablet with yellow color instead of white color
|
28/04/2021 | |
| 67 | DIS/1257/FDA/2021 |
Telmisartan 40mg
|
Galaxy Pharmaceuticals/India
|
BN:FF9016,Mfd:06/2019,Exp:05/2022 | Retail | Class II |
The tablet broken down easily
|
14/04/2021 | |
| 68 | DIS/1256/FDA/2021 |
AGOMYCIN Suspension (Erythromycin Estolate Oral Suspension 125mg/5ml),
|
Agog Pharma Limited, India
|
BN:L96013,Mfd:11/2019,Exp:10/2022 | Retail | Class II |
Low level of Content of Erythromycin Estolate eq. to
Erythromycin,36.476mgl5m1. while normal range should be 112.50 - 143.75mg15m|,
|
14/04/2021 | |
| 69 | 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
|
12/01/2021 | |
| 70 | Ref No.:DIS/046/FDA/2021 |
Unibrol(Aminosidine)250mg
|
Universal corporation/Kenya
|
BN:5805934,Mfd:02/2019,Exp:01/2022 | Retail | Class II |
Change of color for some tablet with yellow color instead of white color
|
12/01/2021 | |
| 71 | Ref No.:DIS/046/FDA/2021 |
Unibrol(Aminosidine)250mg
|
Universal corporation/Kenya
|
,BN:5807242,Mfd:02/2020,Exp:01/2023 | Retail | Class II |
Change of color for some tablet with yellow color instead of white color
|
12/01/2021 | |
| 72 | DIS/1164/RwandaFDA/2020 |
Benzyl penicillin procaine+DHS
|
PUSHKIN LABORATORY LLC/Russia
|
BN:MI12-06,Mfd:01/2019,Exp:01/2021 | Retail | Class II |
Precipitation of the product with crystallization
|
06/12/2020 | |
| 73 | DIS/1164/RwandaFDA/2020 |
Benzyl penicillin procaine+DHS
|
PUSHKIN LABORATORY LLC/Russia
|
BN:MI12-07,Mfd:01/2019,Exp:06/2022 | Retail | Class II |
Precipitation of the product with crystallization
|
06/12/2020 | |
| 74 | DIS/1164/RwandaFDA/2020 |
Benzyl penicillin procaine+DHS
|
PUSHKIN LABORATORY LLC/Russia
|
BN:MI12-08,Mfd:01/2019,Exp:01/2021 | Retail | Class II |
Precipitation of the product with crystallization
|
06/12/2020 | |
| 75 | DIS/1164/RwandaFDA/2020 |
Benzyl penicillin procaine+DHS
|
PUSHKIN LABORATORY LLC/Russia
|
BN:MI12-09,Mfd:01/2019,Exp:01/2021 | Retail | Class II |
Precipitation of the product with crystallization
|
06/12/2020 | |
| 76 | DIS/1164/RwandaFDA/2020 |
Benzyl penicillin procaine+DHS
|
PUSHKIN LABORATORY LLC/Russia
|
BN:MI12-10,Mfd:02/2019,Exp:02/2021 | Retail | Class II |
Precipitation of the product with crystallization
|
06/12/2020 | |
| 77 | DIS/1164/RwandaFDA/2020 |
Benzyl penicillin procaine+DHS
|
PUSHKIN LABORATORY LLC/Russia
|
BN:MI12-11,Mfd:02/2019,Exp:02/2021 | Retail | Class II |
Precipitation of the product with crystallization
|
06/12/2020 | |
| 78 | DIS/1164/RwandaFDA/2020 |
Benzyl penicillin procaine+DHS
|
PUSHKIN LABORATORY LLC/Russia
|
BN:MI12-12,Mfd:03/2019,Exp:03/2021 | Retail | Class II |
Precipitation of the product with crystallization
|
06/12/2020 | |
| 79 | Ref.No.: DIS/2887/FDA/2020 |
Unibrol(Aminosidine)250mg
|
Universal corporation/Kenya
|
,BN:586898,Mfd:09/2019,Exp:08/2022 | Retail | Class II |
Color change for some tablet within blisters
|
29/11/2020 | |
| 80 | DIS/1153/RwandaFDA/2020 |
Huureka Disinfectant
|
KEWS CORPORATION/SOUTH KOREA
|
ALL BATCHES | Retail | Class II |
Suspected poor quality product
|
06/11/2020 | |
| 81 | Ref.No: DIS/2419/FDA/2020 |
NEMCHEM Terminal Hand Sanitizer(Ethanol based),
|
NEM CHEM INTERNATIONAL
|
BN:0076,Mfd:20/03/2020,Exp:20/03/2022 | Retail | Class II |
Alcohol content at low level
|
25/10/2020 | |
| 82 | Ref.No.:DIS/2385/FDA/2020 |
Pure Skin Stay Safe Hand Sanitizer (Ethanol based)
|
Africana Buffalo Ltd/Kigali,Gasabo
|
BN:001,Mfd:May 2020,Exp:April 2022 | Retail | Class II |
Alcohol content at low level
|
21/10/2020 | |
| 83 | DIS/1876/FDA/2020 |
Complex Multivitamine injection veterinary medicine
|
HebeiChengSheng Tang Animal Pharmaceuticals Co Ltd
|
BN: 190813, EXP: 08/2022 | Retail | Class II |
Lack of storage condition on the labeling
|
31/08/2020 | |
| 84 | DIS/1876/FDA/2020 |
Complex Multivitamine injection veterinary medicine
|
HebeiChengSheng Tang Animal Pharmaceuticals Co Ltd
|
BN:190917, EXP: 09/2022 | Retail | Class II |
Lack of storage condition on the labeling
|
31/08/2020 | |
| 85 | DIS/1876/FDA/2020 |
Novalgine injection 50%
|
HebeiChengSheng Tang Animal Pharmaceuticals Co Ltd
|
BN : 80608 , EXP06/2021 | Retail | Class II |
Lack of storage condition on the labeling
|
31/08/2020 | |
| 86 | DIS/1876/FDA/2020 |
Novalgine injection 50%
|
HebeiChengSheng Tang Animal Pharmaceuticals Co Ltd
|
BN:190729A , EXP 07/2022 | Retail | Class II |
Lack of storage condition on the labeling
|
31/08/2020 | |
| 87 | DIS/1876/FDA/2020 |
Ivermectine injection 1%
|
HebeiChengSheng Tang Animal Pharmaceuticals Co Ltd
|
BN:180617, EXP: 06/2021 | Retail | Class II |
Lack of storage condition on the labeling
|
31/08/2020 | |
| 88 | DIS/1877/FDA/2020 |
(Acaricide)Amitraz 12,5% EC
|
HebeiChengSheng Tang Animal Pharmaceuticals Co Ltd
|
GA20181110 | Retail | Class II |
Lack of storage condition and evaporation of the products
|
31/08/2020 | |
| 89 | DIS/1940/FDA/2020 |
Guard Hand Sanitizer 30ml Mfd:10/03/2020,10/03/2021
|
KVMS Co. Ltd,Tel: 250788851252
|
All mfg : 10/03/2020;Exp: 10/03/2021 | Retail | Class II |
Failure to meet the quality of standard
|
09/04/2020 | |
| 90 | DIS/1941/FDA/2020 |
Purell-Instant Hand Sanitizer (60ML)
|
BELLA LTD
|
ALL BATCHES | Retail | Class II |
Failure to meet the quality of standard
|
09/04/2020 | |
| 91 | Ref No 496RwandaFDA2020 |
Entamizole DS ( Diloxanide furoate/ metronidazole 500/400mg)
|
ABBOTT LAB/PAKISTAN
|
94965XV (outer package), 95532XV (blister) | Retail | Class II |
batch number and expiry dates on blisters were different from the one on outer package
|
19/03/2020 | |
| 92 | ODG/CRC/002/RwandaFDA/2020 |
Hand Sanitizers Manufactured by Oxalis Ltd
|
Oxalis Ltd
|
ALL BATCHES | Retail | Class II |
Failure to meet the quality of standard
|
15/03/2020 | |
| 93 | ODG/CRC/006/RwandaFDA/2020 |
BEU Hand Sanitizers
|
Holly Trust Ltd/Kamonyi District
|
ALL BATCHES | Retail | Class II |
Failure to meet the quality of standard
|
04/03/2020 | |
| 94 | Ref. No 260 / RwandaFDA/ 2020 |
Azithromycine dry powder suspension(Zerocin),
|
Laboratory&Allied Ltd./kenya
|
BN:74261,Mfd:04/2019,Exp date:03/2021 | Retail | Class II |
Caking of the powder in the bottom of the bottles causing poor flowability
|
13/02/2020 | |
| 95 | Ref. No 260 / RwandaFDA/ 2020 |
Azithromycine dry powder suspension(Zerocin),
|
Laboratory&Allied Ltd./kenya
|
BN:74346,Mfd:05/2019,Exp date:04/2021 | Retail | Class II |
Caking of the powder in the bottom of the bottles causing poor flowability
|
13/02/2020 | |
| 96 | DIS/2129/FDA/2020 |
Lime Fresh Hand Sanitizer and disinfectants
|
Lime Fresh Family Ltd
|
ALL BATCHES | Retail | Class II |
The hand sanitiser do not contain Alcohol
|
10/02/2020 | |
| 97 | DIS/1311/RwandaFDA/2020 |
Safe Hands Sanitizers-Instant Hand Sanitizer
|
KVM Co LTD
|
ALL BATCHES | Retail | Class II |
Poor quality Suspect
|
07/01/2020 | |
| 98 | Ref No.1539/Rwanda FDA/2019 |
Paracetamol suspension 120mg/5ml (Toto-moL®),
|
Laboratory&Allied Ltd./kenya
|
B.N: 73718,mfg date: 02/2019, exp date: 01/2022 | Retail | Class II |
The product was detected with particulate matter
|
20/11/2019 | |
| 99 | Ref No. 1722/RwandaFDA/2019 |
Urinalysis reagents strips with 3Parameters,
|
Not mentioned
|
BN:UR35111906A,Exp date:06/2021 | Retail | Class II |
Manufacturing date,manufacturer's name and Manufacturer adress were not mentionned
|
12/09/2019 | |
| 100 | Ref No. 1722/RwandaFDA/2019 |
Urinalysis reagents strips with 3Parameters,
|
Not mentioned
|
BN:UR105111906A,Exp date:06/2021 | Retail | Class II |
Manufacturing date,manufacturer's name and Manufacturer adress were not mentionned
|
12/09/2019 | |
| 101 | Ref No 0879/RwandaFDA/2019 |
Envit 100 ml,
|
Vitindia Pharmaceuticals Ltd A-6/1 India
|
B.N: EEV1807, Exp date: 07/2020 | Retail | Class II |
The solution had issue of sedimentation
|
25/07/2019 | |
| 102 | Ref No 0879/RwandaFDA/2019 |
Envit 100 ml,
|
Vitindia Pharmaceuticals Ltd A-6/1 India
|
B.N: EEV1808, Exp date: 07/2020 | Retail | Class II |
The solution had issue of sedimentation
|
25/07/2019 | |
| 103 | Ref No 0879/RwandaFDA/2019 |
Envit 100 ml,
|
Vitindia Pharmaceuticals Ltd A-6/1 India
|
B.N:EEV 1713,Exp date:10/2019 | Retail | Class II |
The solution had issue of sedimentation
|
25/07/2019 | |
| 104 | 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
|
18/06/2019 | |
| 105 | Ref.No.0638/Rwanda FDA/2019 |
Silver Sulfadiazine Cream USP 1% (Agoburn),
|
Agog Pharma Ltd., India
|
BN: K82001, Exp date: 02/2021 | Retail | Class II |
Failed the Assay (82.2%) test in Lab Quality control tests
|
18/06/2019 | |
| 106 | Ref.No.0638/Rwanda FDA/2019 |
Chloramphenicol 0.5% w/v Eye Drops B.P;
|
Abacus Parenteral Drugs Ltd., Uganda
|
BN: 131936, Exp date: 01/2021 | Retail | Class II |
Failed the Assay test (77.1%) and the degradation product content.
|
18/06/2019 | |
| 107 | Ref No/0310/Rwanda FDA/2019 |
Dexamethasone 4mg/ml
|
JIANGXI XIERKANGTAI PHARMACETICAL CO. LTD/CHINA
|
BN: 180468, Mfg date: 04/2018, Exp date: 03/2021 | Retail | Class II |
The route of administration was not mentioned
|
14/03/2019 | |
| 108 | Ref No.0162/Rwanda FDA /2019 |
Hydralazine 20mg/ml
|
SWISS PARANTERALS Ltd
|
BN: SX-18275; Mfg date: 07/2018,EXP: 06/2020 | Retail | Class II |
The manufacturer declared that they have failed to on-going stabilitity studies and urged the recall
|
21/02/2019 | |
| 109 | Ref No.0162/Rwanda FDA /2019 |
Hydralazine 20mg/ml
|
SWISS PARANTERALS ltd
|
BN: SX-18287 ,Mfg date: 07/2018; EXP: 06/2020 | Retail | Class II |
the manufacturer declared that they have failed to on-going stabilitity studies and urged the recall
|
21/02/2019 |