Rwanda Food and Drugs Authority · Rwanda
DEA-RW-2019-74222469
Tier 1 · Regulator-publishedClass IسحبStatus · active
- Issuing authority
- Rwanda Food and Drugs Authority (RWANDAFDA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 18 Jun 2019
- Recorded by us
- 2026-09-06 18:40:27 UTC
- المستحضر
- Biperiden.HCl Sterop Tablets 2 mg
- 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
- Lab. STEROP NV, Belgium
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- أرقام التشغيلات
- 18B05
- تواريخ انتهاء الصلاحية
- 2023-01
- Action type
- سحب
- التصنيف
- Class I as issued
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- شوائب
- Product type
- دواء
- 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
- نص الإخطار
- The medicine was found with higher rate of impurities in Laboratory quality control testsOriginal language: en
- الحالة
- سارٍ
- Superseded by
- Not superseded.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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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-RW-0000-86468251 | 07 Oct 2021 | RW | Losar-Denk 50 mg film Coated DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
| DEA-RW-0000-51547910 | 07 Oct 2021 | RW | Losar-Denk 25 mg film Coated DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
| DEA-RW-0000-40943378 | 07 Oct 2021 | RW | Colosar-Denk 100 mg /12,5mg film coated tablet DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
| DEA-RW-0000-25020792 | 07 Oct 2021 | RW | Losar-Denk 100 mg film Coated DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
| DEA-RW-0000-16076249 | 07 Oct 2021 | RW | Colosar-Denk 50mg /12,5mg film coated tablet DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
| DEA-UG-2019-36916109 | 31 Oct 2019 | UG | Ranitidine | none published | Import hold | Unclassified | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2019). DEA-RW-2019-74222469: Biperiden.HCl Sterop Tablets 2 mg — سحب, Rwanda Food and Drugs Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/rw/2019/dea-rw-2019-74222469Version 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.