Rwanda Food and Drugs Authority · Rwanda
DEA-RW-2025-71114728
Tier 1 · Regulator-publishedClass IRecallStatus · active
- Issuing authority
- Rwanda Food and Drugs Authority (RWANDAFDA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 03 Jan 2025Format ambiguous in the source; resolved to 2025-01-03 by the table's chronological order.
- Recorded by us
- 2026-09-06 18:40:27 UTC
- Product
- Omiren (Omeprazole Capsules BP 20 mg) BN: 00124 exp. 3/2026
- 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
- RENE INDUSTRIES LTD, Kampala/ Uganda
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Batch numbers
- 00124
- Expiry dates
- 2026-03
- Action type
- Recall
- Classification
- Class I as issued
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Out of specification — dissolution
- 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
- failed to comply with dissolution test specificationsOriginal 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- Superseded by
- Not superseded.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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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-2025-63394553 | 03 Jan 2025 | RW | Captopril 12.5 mg tablets USP Lab & Allied Ltd, Kenya | 85181 | Recall | Class II | Tier 1 · Regulator-published |
| DEA-RW-2019-77457072 | 18 Jun 2019 | RW | Albendazole 400 mg Tablets BN: 370420, Exp date: 08/2022 GlaxoSmithKline South Africa (Pty) Ltd. | 370420 | Recall | Class II | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2025). DEA-RW-2025-71114728: Omiren (Omeprazole Capsules BP 20 mg) BN: 00124 exp. 3/2026 — Recall, Rwanda Food and Drugs Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/rw/2025/dea-rw-2025-71114728Version 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.