Rwanda Food and Drugs Authority · Rwanda
DEA-RW-2024-81231058
Tier 1 · Regulator-publishedClass IRecallStatus · superseded
- Issuing authority
- Rwanda Food and Drugs Authority (RWANDAFDA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 12 Apr 2024Format ambiguous in the source; resolved to 2024-04-12 by the table's chronological order.
- Recorded by us
- 2026-09-06 18:40:27 UTC
- Product
- Benylin Pediatrics Syrup BN:329304, Mfd: May 2021,Exp:April 2024
- 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
- Johnson & Johnson, South Africa
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Batch numbers
- 329304
- 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
- Unacceptable high level of diethylene glycolOriginal language: en
- Status
- Superseded
- Superseded by
- DEA-RW-2024-0088
- 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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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-2019-74222469 | 18 Jun 2019 | RW | Biperiden.HCl Sterop Tablets 2 mg Lab. STEROP NV, Belgium | 18B05 | Recall | Class I | Tier 1 · Regulator-published |
| DEA-RW-2019-57432944 | 18 Jun 2019 | RW | Chloramphenicol 0.5% w/v Eye Drops B.P; Abacus Parenteral Drugs Ltd., Uganda | 131936 | Recall | Class II | Tier 1 · Regulator-published |
| DEA-RW-0000-86468251 | undated | RW | Losar-Denk 50 mg film Coated DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
| DEA-RW-0000-51547910 | undated | RW | Losar-Denk 25 mg film Coated DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
| DEA-RW-0000-40943378 | undated | RW | Colosar-Denk 100 mg /12,5mg film coated tablet DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2024). DEA-RW-2024-81231058: Benylin Pediatrics Syrup BN:329304, Mfd: May 2021,Exp:April 2024 — Recall, Rwanda Food and Drugs Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/rw/2024/dea-rw-2024-81231058Version 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.