Botswana Medicines Regulatory Authority · Botswana
DEA-BW-2024-93841841
Tier 1 · Regulator-publishedUnclassifiedسحبStatus · active
- Issuing authority
- Botswana Medicines Regulatory Authority (BOMRA)
- Authority reference
- Not stated by the issuing authority
- Date issued
- 16 Apr 2024
- Recorded by us
- 2026-09-08 15:48:21 UTC
- المستحضر
- Benylin Paediatric 100mls Cough Syrup
- 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
- Johnson & Johnson (Pty) Ltd
- Manufacturer country
- ZA
- MAH or importer
- Not stated by the issuing authority
- أرقام التشغيلات
- Not published with the notice
- تواريخ انتهاء الصلاحية
- Not published with the notice
- Action type
- سحب
- التصنيف
- Not stated by the issuing authority
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Not stated by the issuing authority
- Product type
- دواء
- ATC code
- Not stated by the issuing authority
- Affected markets
- NG
- Cross-border event
- Benylin Paediatric Syrup — diethylene glycol
- نص الإخطار
- The Botswana Medicines Regulatory Authority (BoMRA) wishes to alert its stakeholders and the public regarding a recent recall notice issued by The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria, for a specific batch of Benylin® Paediatric Syrup. This is a product manufactured by Johnson & Johnson (Pty) Ltd, South Africa. Stakeholders and the public are informed that this recall alert is specific and targeted to certain batches of specified manufacturing and expiry dates.Original language: en
- الحالة
- سارٍ
- Superseded by
- Not superseded. This is the current version.
- Version
- 9
Where this record came from, and what is held to show it.
- Primary source
- https://www.bomra.co.bw/cautionary-statement-on-benylin-paediatric-100mls-cough-syrup-batch-no-329304-and-329303/
- 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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- 62fe1dc7906c8e4fa99fc5d2988e39ac294ec0b6d5b8306683f9e1c5466ada0bSHA-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
- 2026-09-09 10:05:20 UTC
| Reference | Date | Country | Product | Batches | Action | Class | Source |
|---|---|---|---|---|---|---|---|
| DEA-RW-2024-0088 | 12 Apr 2024 | RW | Benylin | 329304 | Recall | Class I | Tier 1 · Regulator-published |
| DEA-ZA-2024-32671519 | 11 Apr 2024 | ZA | Benylin Paediatric Syrup (each 5 ml contains 7 mg Diphenhydramine HCl) Kenvue | 329303 · 329304 | Recall | Class I | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2024). DEA-BW-2024-93841841: Benylin Paediatric 100mls Cough Syrup — سحب, Botswana Medicines Regulatory Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/bw/2024/dea-bw-2024-93841841Version 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.