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
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List of Recalled Products — JULY 2026

Published recalls only. Click View for full details and recall letter.

Total: 124 Class I: 35 Class II: 76 Class III: 9
SN File / Recall No. Medicine Name Manufacturer Batch No. Recall Level Class Safety Issue Reporter Date of Recall Details
1 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
2 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
3 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
4 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
5 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
6 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
7 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
8 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
9 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
10 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
11 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
12 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
13 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
14 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
15 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
16 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
17 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
18 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
19 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
20 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
21 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
22 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
23 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
24 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
25 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
26 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
27 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
28 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
29 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
30 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
31 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
32 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
33 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
34
ANIOS SPECIAL DJP SF 4X5L, B.N:B14316S
Laboratoires Anios
— Retail Class I
The product was reported to be contaminated by a bacteria
KIPHARMA —
35
ANIOS SPECIAL DJP SF 4X5L, B.N:A24104S
Laboratoires Anios
— Retail Class I
The product was reported to be contaminated by a bacteria
KIPHARMA —
Showing 35 of 124 recalls