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:
- 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 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