Pharmacy and Poisons Board · Kenya
DEA-KE-2025-0001
Tier 1 · Regulator-publishedUnclassifiedRecallStatus · active
- Issuing authority
- Pharmacy and Poisons Board (PPB)
- Authority reference
- REC/2025/001
- Date issued
- 03 Jan 2025
- Recorded by us
- 2026-09-06 18:40:27 UTC
- Product
- Bisotrol Tablets
- INN / active substance
- Bisoprolol 5mg
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Manufacturer
- Ipca Laboratories Limited, India
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Batch numbers
- JJI023002
- 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
- Substandard — cause not stated
- Product type
- Medicine
- ATC code
- Not stated by the issuing authority
- Affected markets
- Kenya — no market beyond the issuing country was named on the notice
- Cross-border event
- Not linked to a cross-border event
- Notice text
- Out of specification (OOS) results observed in the Related Substances test of Bisotrol – 5 Tablet at 12M on 30C/75% stability conditions.Original language: en
- Status
- Active
- Superseded by
- Not superseded. This is the current version.
- Version
- 4
Where this record came from, and what is held to show it.
- Primary source
- https://web.pharmacyboardkenya.org/bisotrol/
- 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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- 38eb2702ceb1ac176f31e35450c1baeeb0f885849bb2cb7a62ff83420d28fac0SHA-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 22:56:27 UTC
| Reference | Date | Ctry | Product | Batches | Action | Class | Source |
|---|---|---|---|---|---|---|---|
| DEA-KE-2026-0016 | 28 Jul 2026 | KE | Panto-Denk Denk Pharma GmbH & Co. KG | 6289 · 6288 · 6180 · 6097 · 5823 · 5822 · 5818 · 5628 · 5397 | Recall | Unclassified | Tier 1 · Regulator-published |
| DEA-XXX-2026-0001 | 07 May 2026 | XX | ACCUPAQUE (Iohexol), OMNIPAQUE (Iohexol) and VISIPAQUE (Iodixanol) | none published | Public warning | Unclassified | Tier 1 · Regulator-published |
| DEA-ZA-2026-0061 | 20 Apr 2026 | ZA | Contrast media (iohexol) | none published | Recall | Unclassified | Tier 1 · Regulator-published |
| DEA-ZM-2026-96364594 | 24 Feb 2026 | ZM | Mediquick Disposable Hypodermic Syringe 21g* 1.5 PH Healthcare Pvt.Ltd. India | E010822523 | Recall | Unclassified | Tier 1 · Regulator-published |
| DEA-ZM-2026-82905593 | 06 Feb 2026 | ZM | Cromohist Eye Drops Sodium Cromoglycate Opthalmic Solution USP 2%W/V Leeford Healthcare Limited India | LHE24038 | Recall | Unclassified | Tier 1 · Regulator-published |
| DEA-ZM-2026-70655428 | 29 Jan 2026 | ZM | Vitceetaj Vitamin C Chewable Tablets 100mg Taj Pharmaceuticals Limited, India | TPT24023 | Recall | Unclassified | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2025). DEA-KE-2025-0001: Bisotrol Tablets — Recall, Pharmacy and Poisons Board. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/ke/2025/dea-ke-2025-0001Version 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.