Register / South Africa / DEA-ZA-2025-98097656
South African Health Products Regulatory Authority · South Africa
DEA-ZA-2025-98097656
Tier 1 · Regulator-publishedUnclassifiedRecallStatus · active
- Issuing authority
- South African Health Products Regulatory Authority (SAHPRA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 19 Dec 2025SAHPRA heads this column "Date Updated" rather than the date of the recall.
- Recorded by us
- 2026-09-06 20:25:58 UTC
- Product
- Sodium Fluoride 0.55mg/4 drops equivalent to 0,25 mg fluoride. (Zymafluor Oral Drops)
- 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
- Not stated by the issuing authority
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Batch numbers
- 2304254
- Expiry dates
- Not published with the notice
- Action type
- Recall
- Classification
- Not stated by the issuing authority
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Not stated by the issuing authority
- Product type
- Not stated by the issuing authority
- ATC code
- Not stated by the issuing authority
- Affected markets
- South Africa — no market beyond the issuing country was named on the notice
- Cross-border event
- Not linked to a cross-border event
- Notice text
- Not captured. The notice itself is linked below.
- Status
- Active
- Superseded by
- Not superseded. This is the current version.
- Version
- 3
Where this record came from, and what is held to show it.
- Primary source
- https://www.sahpra.org.za/document/sodium-fluoride-0-55mg-4-drops-equivalent-to-025-mg-fluoride-zymafluor-oral-drops/
- 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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- 3cb1e2f846631c2ae0d26e47a5ba0359358a2837cb36f1e124ed712efaabfb9cSHA-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
- 2026-09-06 20:54:10 UTC
Cite this record
Drug Eye Africa (2025). DEA-ZA-2025-98097656: Sodium Fluoride 0.55mg/4 drops equivalent to 0,25 mg fluoride. (Zymafluor Oral Drops) — Recall, South African Health Products Regulatory Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/za/2025/dea-za-2025-98097656Version 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.