Register / South Africa / DEA-ZA-2022-40914018
South African Health Products Regulatory Authority · South Africa
DEA-ZA-2022-40914018
Tier 1 · Regulator-publishedClass IIIسحبStatus · active
- Issuing authority
- South African Health Products Regulatory Authority (SAHPRA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 22 Apr 2022SAHPRA heads this column "Date Updated" rather than the date of the recall.
- Recorded by us
- 2026-09-06 20:25:58 UTC
- المستحضر
- OsvaRen 435mg_235 film coated tablets
- INN / active substance
- Not stated by the issuing authority
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- الشركة المصنعة
- Fresenius Medical Care South Africa (PTY) Ltd.
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- أرقام التشغيلات
- ZC015 · 200 · ZOAK08100 · ZOAK04 · ZC016100 · ZOAK04300 · ZOAK05200 · ZOAK08300
- تواريخ انتهاء الصلاحية
- Not published with the notice
- Action type
- سحب
- التصنيف
- Class III as issued
- 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
- نص الإخطار
- Not captured. The notice itself is linked below.
- الحالة
- سارٍ
- Superseded by
- Not superseded. This is the current version.
- Version
- 14
Where this record came from, and what is held to show it.
- 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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- 02ead6c6b9d1148f78ec2759963710527c0532e18f4cfd511b9f84d89c06b877SHA-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 20:52:16 UTC
Cite this record
Drug Eye Africa (2022). DEA-ZA-2022-40914018: OsvaRen 435mg_235 film coated tablets — سحب, South African Health Products Regulatory Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/za/2022/dea-za-2022-40914018Version 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.