Medicine Quality Alert: Class III Medicine Recall of Para-Denk 125mg Suppos and Para-Denk 250mg, suppositories
Denk Pharma GmbH & Co. KG has initiated an urgent voluntary recall of Para-Denk 125mg and 250mg Suppos for the batches listed below.
From: Pharmacy and Poisons Board
Date of Recall Initiation: 9th July 2025
Recall Reference Number: REC/2025/021
Recall Classification: Class III
Recall Level: Wholesaler/Distributor level
Manufacturer: RubiePharm Arzneimittel GmbH, Germany
Local Technical Representative: Laborex Kenya Limited
Other Distributors: Omaera Pharmaceuticals Ltd and Symbio Healthcare Ltd
Product name: Para-Denk 125mg Suppos and Para-Denk 250mg Suppos
Active Pharmaceutical Ingredient: Paracetamol 125mg and Paracetamol 250 mg Suppository
Affected counties: All
Affected Batches
Batch Number | Strength | Date of Expiry | Pack Sizes |
28426 | 250 mg | 31.03.2027 | 10’s |
28579 | 250 mg | 31.03.2026 | 10’s |
26906 | 125 mg | 31.07.2025 | 10’s |
27286 | 125 mg | 31.01.2026 | 10’s |
27339 | 125 mg | 31.03.2026 | 10’s |
27342 | 125 mg | 31.05.2026 | 10’s |
27846 | 125 mg | 30.11.2026 | 10’s |
27836 | 250 mg | 30.11.2026 | 10’s |
28422 | 250 mg | 28.02.2027 | 10’s |
28424 | 250 mg | 28.02.2027 | 10’s |
28420 | 125 mg | 28.02.2027 | 10’s |
28458 | 125 mg | 30.04.2027 | 10’s |
27670 | 125 mg | 31.05.2026 | 10’s |
27672 | 125 mg | 30.06.2026 | 10’s |
27291 | 250 mg | 31.12.2025 | 10’s |
27343 | 250 mg | 28.02.2026 | 10’s |
27674 | 250 mg | 31.03.2026 | 10’s |
27821 | 250 mg | 30.06.2026 | 10’s |
27822 | 250 mg | 30.06.2026 | 10’s |
Brief description of the problem
The product is being recalled due to packaging damage, causing leakages in some batches of the suppositories.
Action for healthcare professionals
Stop supplying the above batches immediately. Quarantine all remaining stock and await contact from Laborex Kenya Limited to arrange the return.
Action for patients and carers
No further action is required by patients as this is a Wholesaler/Distributor level recall.
Further Information
For inquiries about consignments of the impacted batches, please contact Laborex Kenya Limited at ssavla@laborex-healthcare.com or via telephone at +254 (0) 20 69 39 162 or +254 769 579 060, Omaera Pharmaceuticals Ltd at: omaera@africaonline.co.ke, +254 728 970 777, +254 722 701 312, and Symbio Healthcare Ltd at: steve.denk@yahoo.com or Tel +254 722 203 050
Promptly report any cases of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:
- https://pv.pharmacyboardkenya.org/users/mpublic
- USSD code at *271#
- Email pv@ppb.go.ke or pms@ppb.go.ke
- Telephone No. 0795743049
For any further enquiries and feedback on the product recall, contact the post-marketing surveillance unit at the Pharmacy and Poisons Board via email at pms@ppb.go.ke
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Medicine Quality Alert: Class III Recall of Para-Denk 125mg Suppos and 250mg Suppos, suppositories