Medicine Quality Alert: Class II Medicines Recall of Panto-Denk 40 mg (Pantoprazole Sodium Sesquihydrate), Batch Nos.6289, 6288, 6180, 6097, 5823, 5822, 5818, 5628 and 5397.
Denk Pharma GmbH & Co. KG through Laborex Kenya Limited has initiated a voluntary recall of Panto-Denk 40 mg (Pantoprazole Sodium Sesquihydrate), following the identification of a quality defect during ongoing stability studies, whereby the above-listed batches failed to meet the approved dissolution specification (buffer stage) at the 24-month (T24) long-term stability testing interval under storage conditions of 30°C/75% RH.
From: Pharmacy and Poisons Board
Published: 28th July 2026
Recall Reference Number: REC/2026/16
Recall Classification: Class II
Recall Level: Retail/Facility Level
Manufacturer: Denk Pharma GmbH & Co. KG
LTR: Laborex Kenya Limited
Product name: Panto-Denk 40 mg
Active Pharmaceutical Ingredient: Pantoprazole Sodium Sesquihydrate
Affected counties: All
Affected Batches
S/N | Batch No | Mfg Date | Exp Date |
1. | 6289 | 25.08.2024 | 31.08.2027 |
2. | 6288 | 11.08.2024 | 31.08.2027 |
3. | 6180 | 05.02.2025 | 29.02.2028 |
4. | 6097 | 05.02.2025 | 29.02.2028 |
5. | 5823 | 21.05.2024 | 31.05.2027 |
6. | 5822 | 21.05.2024 | 31.05.2027 |
7. | 5818 | 29.04.2024 | 30.04.2027 |
8. | 5628 | 31.01.2024 | 31.01.2027 |
9. | 5397 | 15.06.2023 | 30.06.2026 |
Brief description of the problem
The voluntary recall has been initiated due to an observation of the identification of a quality defect during ongoing stability studies, whereby the listed batches failed to meet the approved dissolution specification (buffer stage) at the 24-month (T24) long-term stability testing interval under storage conditions of 30°C/75% RH.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing, or use of Panto-Denk 40 mg (Pantoprazole Sodium Sesquihydrate), Batch Nos.6289, 6288, 6180, 6097, 5823, 5822, 5818, 5628 and 5397 immediately and contact Laborex Kenya Limited to arrange return.
Action for patients and caregivers
Patients are advised to talk to their healthcare professional if they have the above batches of Panto-Denk 40mg.
Further Information
For any inquiries on consignments, please contact Laborex Kenya Limited by email at ssavla@laborex-healthcare.com or via telephone at 0722-449999/0733-449990
Promptly report any case/s of suspected substandard and falsified products or adverse reactions or insufficient control of symptoms to the nearest healthcare facility or the Pharmacy and Poisons Board 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
- Mobile application: mPvERS both Android and iOS
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 II Recall of Panto-Denk 40 mg (Pantoprazole Sodium Sesquihydrate), Batch Nos.6289, 6288, 6180, 6097, 5823, 5822, 5818, 5628 and 5397