Rwanda Food and Drugs Authority · Rwanda
DEA-RW-2019-77457072
Tier 1 · Regulator-publishedClass IIRecallStatus · active
- Issuing authority
- Rwanda Food and Drugs Authority (RWANDAFDA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 18 Jun 2019
- Recorded by us
- 2026-09-06 18:40:27 UTC
- Product
- Albendazole 400 mg Tablets BN: 370420, Exp date: 08/2022
- 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
- GlaxoSmithKline South Africa (Pty) Ltd.
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Batch numbers
- 370420
- Expiry dates
- Not published with the notice
- Action type
- Recall
- Classification
- Class II 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
- The product failed to dissolution test in Lab Quality control testsOriginal 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- Superseded by
- Not superseded.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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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-2025-71114728 | 03 Jan 2025 | RW | Omiren (Omeprazole Capsules BP 20 mg) BN: 00124 exp. 3/2026 RENE INDUSTRIES LTD, Kampala/ Uganda | 00124 | Recall | Class I | Tier 1 · Regulator-published |
| 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 |
Cite this record
Drug Eye Africa (2019). DEA-RW-2019-77457072: Albendazole 400 mg Tablets BN: 370420, Exp date: 08/2022 — Recall, Rwanda Food and Drugs Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/rw/2019/dea-rw-2019-77457072Version 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.