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