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Medicine Quality Alert: Class II Medicine Recall of Lipiloc (Fenofibrate 200mg) Tablets Batch Number OGT-095

The Pharmacy and Poisons Board has mandated Galaxy Pharmaceuticals Ltd to conduct an urgent recall of Lipiloc Tablets Batch Number OGT-095

From: Pharmacy and Poisons Board

Published: 23rd September 2024

Recall Reference Number: REC/2024/024

Recall Classification: Class II

Recall Level: Retail/Facility level

Local Technical Representative (LTR): Galaxy Pharmaceutical Ltd

Manufacturer: Ovation Remedies, India

Product name: Lipiloc tablets

Active Pharmaceutical Ingredient: Fenofibrate 200mg

Affected counties: All

Affected Batch

Batch Number

Date of Manufacture

Date of expiry

Pack Size

OGT-095

08/2023

07/2026

30 Tablets

 

Brief description of the problem

The Pharmacy and Poisons Board has mandated Galaxy Pharmaceuticals Ltd to conduct an urgent recall of Lipiloc Tablets Batch Number OGT-095 following OOS results on dissolution.

Action for healthcare professionals

Quarantine all remaining stock and stop further distribution, sale, issuing or use of the above batches immediately. Await contact from Galaxy Pharmaceutical Ltd to arrange the return.

Action for patients and caregivers

No further action is required by patients as this is a Retail/hospital Pharmacy and Wholesaler/Distributor level recall. You are advised to talk to your healthcare professional if you have the above batches of Azithrosafe Suspension. The patients should continue taking other batches of the product other than the impacted batches and as prescribed by the healthcare professional.

 Further Information

For inquiries about consignments of the impacted batches, please contact Galaxy Pharmaceutical Ltd at: info@galaxypharma.co.ke or pvigilance@galaxypharma.co.ke or by Telephone at: +254 3748551/2/3/4

You are advised to promptly report any case(s) of adverse events and suspected substandard and falsified products to the nearest healthcare facility or 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 and Recall Feedback Form

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Medicine Quality Alert: Class II Medicine Recall of Lipiloc (Fenofibrate 200mg) Tablets Batch Number OGT-095