RECORDS ARE PUBLISHED REGULATORY ACTIONS. FIELDS THE ISSUING AUTHORITY DID NOT PUBLISH ARE MARKED AS NOT STATED, NEVER FILLED IN.
Drug Eye AfricaNational Actions, Continental Reach
Register / Rwanda / DEA-RW-2021-53901946
Rwanda Food and Drugs Authority · Rwanda
DEA-RW-2021-53901946
Tier 1 · Regulator-publishedClass IIRecallStatus · 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
Product
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
Manufacturer
DAWA Limited/ KENYA
Manufacturer country
Not stated by the issuing authority
MAH or importer
Not stated by the issuing authority
Batch numbers
2006004
Expiry dates
2022-05
Action type
Recall
Classification
Class II as issued
Indicative severity
Not assessed by Drug Eye Africa
Defect category
Microbial contamination
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
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 bottles
Original language: en
Status
Active
Superseded by
Not superseded. This is the current version.
Version
5

Provenance

Verification tier 1

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Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
59b5df2a915961d640cf3bc473e9d7b9830b37b39d3b5573d2730905fba91d45
SHA-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

Related actions elsewhere

Same stated defect
ReferenceDateCtryProductBatchesActionClassSource
DEA-XXX-2013-000417 Oct 2013XXDextromethorphan UPDATEnone publishedPublic warningUnclassifiedTier 1 · Regulator-published
DEA-XXX-2013-000124 Jan 2013XXDextromethorpan Active Pharmaceutical Ingredientnone publishedPublic warningUnclassifiedTier 1 · Regulator-published
Cite this record
Drug Eye Africa (2021). DEA-RW-2021-53901946: Nystatin oral suspension BP 100 000 IU/ml — Recall, Rwanda Food and Drugs Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/rw/2021/dea-rw-2021-53901946

Version 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.

This record as data

/api/v1/notices/DEA-RW-2021-53901946