Rwanda Food and Drugs Authority · Rwanda
DEA-RW-2025-33798723
Tier 1 · Regulator-publishedClass IIRecolhaStatus · active
- Issuing authority
- Rwanda Food and Drugs Authority (RWANDAFDA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 25 Aug 2025
- Recorded by us
- 2026-09-06 18:40:27 UTC
- Produto
- PROSTREP 20/20 INJ 100ml (Procaine Benzyl Penicillin 200mg, Dihydrostreptomycin Sulphate 200mg)
- INN / active substance
- Not stated by the issuing authority
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Fabricante
- ModHike Private Limited
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Números de lote
- MV32-002
- Prazos de validade
- Not published with the notice
- Action type
- Recolha
- Classificação
- Class II as issued
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Not stated by the issuing authority
- Product type
- Medicamento
- 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
- Texto do aviso
- Precipitates in solution and color change from white to yellowOriginal language: en
- Estado
- Em vigor
- Superseded by
- Not superseded. This is the current version.
- Version
- 13
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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- 60f6d564c1222b3b6ec906daff230258c238d352b147c51672d47f194babea72SHA-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
- 2026-09-11 09:58:19 UTC
Cite this record
Drug Eye Africa (2025). DEA-RW-2025-33798723: PROSTREP 20/20 INJ 100ml (Procaine Benzyl Penicillin 200mg, Dihydrostreptomycin Sulphate 200mg) — Recolha, Rwanda Food and Drugs Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/rw/2025/dea-rw-2025-33798723Version 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 Records are superseded, never deleted.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.