Rwanda Food and Drugs Authority · Rwanda
DEA-RW-2021-34272329
Tier 1 · Regulator-publishedClass IRecallStatus · active
- Issuing authority
- Rwanda Food and Drugs Authority (RWANDAFDA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 25 May 2021
- Recorded by us
- 2026-09-06 18:40:27 UTC
- Product
- Hyoscine Butylbromide Injection BP 20mg/ml,
- INN / active substance
- Not stated by the issuing authority
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Batch numbers
- 3H20001
- Expiry dates
- 2022-06
- Action type
- Recall
- Classification
- Class I as issued
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Particulate matter
- Product type
- Medicine
- ATC code
- Not stated by the issuing authority
- Affected markets
- Rwanda — no market beyond the issuing country was named on the notice
- Cross-border event
- Not linked to a cross-border event
- Notice text
- Presence of Particulate matters in Vials and Piece of broken glass in the ampouleOriginal language: en
- Status
- Active
- Superseded by
- Not superseded. This is the current version.
- Version
- 5
Where this record came from, and what is held to show it.
- Primary source
- https://monitoring.rwandafda.gov.rw/recalls/
- Copy of the source
- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn. Not yet published at an address you can open.Ask us for it and check it against the fingerprint below.
- Fingerprint
- 59b5df2a915961d640cf3bc473e9d7b9830b37b39d3b5573d2730905fba91d45SHA-256 of the copy held. Any file that produces this number is that copy, byte for byte; any file that does not is a different document.
- Copy taken
- 2026-09-08 12:29:55 UTC
| Reference | Date | Ctry | Product | Batches | Action | Class | Source |
|---|---|---|---|---|---|---|---|
| DEA-RW-2025-38192882 | 20 Aug 2025 | RW | Lidocaine 2% injection 30ml Merit Organic Ltd (India) | I02171 | Recall | Class II | Tier 1 · Regulator-published |
| DEA-KE-2025-0028 | 20 Aug 2025 | KE | Paradol Dinlas Pharma | 240831 · 240181 · 240158 · 230215 · 240051 · 230172 · 240213 | Recall | Unclassified | Tier 1 · Regulator-published |
| DEA-RW-2025-94679536 | 15 Jul 2025 | RW | Lidocaine 2% injection 30ml Merit Organic Ltd (India) | I02161 | Recall | Class II | Tier 1 · Regulator-published |
| DEA-RW-2025-83945852 | 15 Jul 2025 | RW | Lidocaine 2% injection 30ml Merit Organic Ltd (India) | I02173 | Recall | Class II | Tier 1 · Regulator-published |
| DEA-RW-2025-78615184 | 15 Jul 2025 | RW | Lidocaine 2% injection 30ml Merit Organic Ltd (India) | I02166 | Recall | Class II | Tier 1 · Regulator-published |
| DEA-RW-2025-67911025 | 15 Jul 2025 | RW | Lidocaine 2% injection 30ml Merit Organic Ltd (India) | I02172 | Recall | Class II | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2021). DEA-RW-2021-34272329: Hyoscine Butylbromide Injection BP 20mg/ml, — Recall, Rwanda Food and Drugs Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/rw/2021/dea-rw-2021-34272329Version history
—No version history recorded for this record.
—Corrections appear here and in the site-wide log. Records are superseded, never deleted.
Verification
Tier 1 — Published by the issuing regulator on its own channel and captured by Drug Eye Africa, with the source document archived.
Indexing
This record is indexable: it is dated, names a product, and carries either a batch number or a stated reason.