Rwanda Food and Drugs Authority · Rwanda
DEA-RW-0000-16076249
Tier 1 · Regulator-publishedClass IRecallStatus · active
- Issuing authority
- Rwanda Food and Drugs Authority (RWANDAFDA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 07 Oct 2021Taken from the "Date of Recall" cell. The column is day-first: 121 of its values have a first component above 12 and none have a second above 12, which settles the ambiguity this record was previously held open for.
- Recorded by us
- 2026-09-06 18:40:27 UTC
- Product
- Colosar-Denk 50mg /12,5mg film coated tablet
- 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
- DENK PHARMA
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Batch numbers
- Not published with the notice
- Expiry dates
- Not published with the notice
- Action type
- Recall
- Classification
- Class I as issued
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Impurity
- 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
- Genotoxic impurity detected in APIOriginal language: en
- Status
- Active
- Superseded by
- Not superseded. This is the current version.
- Version
- 6
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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- caea2b6c82061d0f0d7544778912ecb9e3f778399227e273568f7e06e938a294SHA-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
- 2026-09-09 10:03:33 UTC
| Reference | Date | Ctry | Product | Batches | Action | Class | Source |
|---|---|---|---|---|---|---|---|
| DEA-RW-2024-81231058 | 12 Apr 2024 | RW | Benylin Pediatrics Syrup BN:329304, Mfd: May 2021,Exp:April 2024 Johnson & Johnson, South Africa | 329304 | Recall | Class I | Tier 1 · Regulator-published |
| DEA-RW-0000-86468251 | 07 Oct 2021 | RW | Losar-Denk 50 mg film Coated DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
| DEA-RW-0000-51547910 | 07 Oct 2021 | RW | Losar-Denk 25 mg film Coated DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
| DEA-RW-0000-40943378 | 07 Oct 2021 | RW | Colosar-Denk 100 mg /12,5mg film coated tablet DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
| DEA-RW-0000-25020792 | 07 Oct 2021 | RW | Losar-Denk 100 mg film Coated DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2021). DEA-RW-0000-16076249: Colosar-Denk 50mg /12,5mg film coated tablet — Recall, Rwanda Food and Drugs Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/rw/2021/dea-rw-0000-16076249Version 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.