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Medicine Quality Alert: Class II Medicine Recall of Rabemac (Rabeprazole) Batch No. ERW23001C and ERW22003A

Sai Pharmaceuticals Ltd has initiated an urgent voluntary recall of  Rabemac (Rabeprazole 20mg) Batch No. ERW23001C and ERW22003A

From: Pharmacy and Poisons Board

Published: 14th August 2024

Recall Reference Number: REC/2024/020

Recall Classification: Class II

Recall Level: Retail-level

Local Technical Representative: Sai Pharmaceuticals Ltd, Kenya

Manufacturer: Macleods Pharmaceutical Limited, India

Product name: Rabemac

Active Pharmaceutical Ingredient: Rabeprazole 20mg

Affected Counties: All

Affected Batches

Batch Number

Date of Manufacture

Date of expiry

Pack Size

ERW23001C

04/2023

03/2025

30 Tablets

ERW22003A

10/2022

09/2024

30 Tablets

 

Brief description of the problem

The product is being recalled following Out of Specification (OOS) result observed in the assay value of Rabeprazole Sodium Tablets 20mg under 30°C/75% RH. The OOS was 88.0% against the specification limit of NLT 90.0% and NMT 107.5% of the labelled amount.

Action for healthcare professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and await contact from Sai Pharmaceuticals Ltd, to arrange the return.

Action for patients and carers

Patients currently prescribed Rabemac (Rabeprazole) Batch No. ERW23001C and ERW22003A should be contacted by their prescribing healthcare professional. This is because you require a review with your prescribing healthcare professional to discuss alternative treatment options.

Further Information

For medical information inquiries please contact Sai Pharmaceuticals Ltd, at: Head-regulatory@saipharm.com   or via telephone: +254 741 141 780

Promptly report any cases of adverse events and suspected substandard and falsified products to the nearest healthcare facility or through the following channels:

For any further information please contact the Pharmacy and Poisons Board by email: pms@ppb.go.ke

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Medicine Quality Alert: Class II Medicine Recall of Rabemac (Rabeprazole) Batch No. ERW23001C and ERW22003A