Rwanda Food and Drugs Authority · Rwanda
DEA-RW-2021-53901946
Tier 1 · Regulator-publishedClass IIRappelStatus · active
- Issuing authority
- Rwanda Food and Drugs Authority (RWANDAFDA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 25 May 2021
- Recorded by us
- 2026-09-06 18:40:27 UTC
- Produit
- Nystatin oral suspension BP 100 000 IU/ml
- INN / active substance
- Not stated by the issuing authority
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Fabricant
- DAWA Limited/ KENYA
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Numéros de lot
- 2006004
- Dates de péremption
- 2022-05
- Action type
- Rappel
- Classification
- Class II as issued
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Contamination microbienne
- Product type
- Médicament
- 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
- Texte de l’avis
- More than 10 bottles were found with a solid lower sediment which is very difficult to shake to the homogeneous status, and several bottles seem to have developed microbial growths that led to the cloudy/misty appearance in the bottlesOriginal language: en
- Statut
- En vigueur
- Superseded by
- Not superseded.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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
| Reference | Date | Country | Product | Batches | Action | Class | Source |
|---|---|---|---|---|---|---|---|
| DEA-XXX-2013-0004 | 17 Oct 2013 | XX | Dextromethorphan UPDATE INDUFAR C.S.I.A. | none published | Public warning | Unclassified | Tier 1 · Regulator-published |
| DEA-XXX-2013-0001 | 24 Jan 2013 | XX | Dextromethorpan Active Pharmaceutical Ingredient Konduskar Laboratories Private Limited | none published | Public warning | Unclassified | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2021). DEA-RW-2021-53901946: Nystatin oral suspension BP 100 000 IU/ml — Rappel, Rwanda Food and Drugs Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/rw/2021/dea-rw-2021-53901946Version 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.