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 | 09072025DENK |
Para-Denk 125 mg Suppos
|
DENK PHARMA
|
ALL BATCHES | Retail | Class III |
packaging damages (leakages) in some batches of its Para-Denk suppositories
|
09/07/2025 | |
| 2 | 09072025DENK |
Para-Denk 250 mg Suppos
|
Denk Pharma GmbH & Co. KG
|
ALL BATCHES | Retail | Class III |
packaging damages (leakages) in some batches of its Para-Denk suppositories
|
09/07/2025 | |
| 3 | DIS/CRC/007/Rwanda FDA/ 2020 |
Ketoconazole (kenazole) cream USP 2% W/W
|
DAWA Limited/ KENYA
|
BN: 1907205 , EXP. 06/2022 | Retail | Class III |
Compromised seal integrity of packs and leakage of the cream
|
04/04/2020 | |
| 4 | Ref.No. 495 /RwandaFDA/2020 |
Cloxacillin 250 mg capsules,
|
REYOUNG PHARMACEUTICAL.CO.LTD/CHINA
|
B.N: 1831132401, Mfg date: 12/2018, Exp. Date: 12/2021 | Retail | Class III |
Capsules were reported self-opening when they are going to be dispensed
|
19/03/2020 | |
| 5 | Ref.No. 495 /RwandaFDA/2020 |
Cloxacillin BP 250 mg capsules,
|
REYOUNG PHARMACEUTICAL.CO.LTD/CHINA
|
B.N: 183132400, Mfg date: 12/2018, Exp date: 12/2021 | Retail | Class III |
Capsules were reported self-opening when they are going to be dispensed
|
19/03/2020 | |
| 6 | Ref No 494/RwandaFDA/2020 |
Amoxycillin BP 250 mg capsules,
|
CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG CO.LTD ) / HEBEI /CHINA
|
B.N: 767190217; Mfg date: 02/2019; Exp date: 02/2022 | Retail | Class III |
Capsules were reported self-opening when they are going to be dispensed
|
19/03/2020 | |
| 7 | Ref.No. 495 /RwandaFDA/2020 |
Cloxacillin BP 250 mg capsules,
|
REYOUNG PHARMACEUTICAL.CO.LTD/CHINA
|
B.N: 183132399 , Mfg date: 12/2018, Exp date: 12/2021 | Retail | Class III |
Capsules were reported self-opening when they are going to be dispensed
|
19/03/2020 | |
| 8 | Ref No 494/RwandaFDA/2020 |
Amoxicilline 250 mg capsules
|
CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG CO.LTD ) / HEBEI /CHINA
|
B.N 767190205, Mfg date: 02/2019, Exp date: 02/2022 | Retail | Class III |
The medicines were reported to self opening and powder leakage
|
19/03/2020 | |
| 9 | Ref No 494/RwandaFDA/2020 |
Amoxycillin BP 250 mg capsules (AMOXIMED)/1000 capsules,
|
CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG CO.LTD ) / HEBEI /CHINA
|
B.N: 767190207, mfg date:02/2019, exp date: 02/2022 | Retail | Class III |
The medicines were reported to self opening and powder leakage
|
19/03/2020 | |
| 10 | Ref No 494/RwandaFDA/2020 |
Amoxycillin BP 250 mg capsules (AMOXIMED)/1000 capsules,
|
CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG CO.LTD ) / HEBEI /CHINA
|
B.N: 767190208, mfg date:02/2019, exp date: 02/2023 | Retail | Class III |
The medicines were reported to self opening and powder leakage
|
19/03/2020 | |
| 11 | Ref No 494/RwandaFDA/2020 |
Amoxycillin BP 250 mg capsules (AMOXIMED)/1000 capsules,
|
CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG CO.LTD ) / HEBEI /CHINA
|
B.N: 767190216, mfg date:02/2019, exp date: 02/2024 | Retail | Class III |
The medicines were reported to self opening and powder leakage
|
19/03/2020 |