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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:

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

 

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