Medicine Quality Alert: Class II Medicine Recall of Haemaccel (Polygeline) Injection, Batch Number HA3004
Piramal Pharma Limited has initiated an urgent voluntary recall of Hemaccel (Polygeline) Injection Batch Number HA3004
From: Pharmacy and Poisons Board
Published: 22nd March 2024
Recall Reference Number: REC/2024/006
Recall Classification: Class II
Recall Level: Retail/Facility Level
Local Technical Representative (LTR): Galaxy Pharmaceutical Ltd
Manufacturer: Piramal Pharma Limited
Product name: Haemaccel 500ml Injection
Active Pharmaceutical Ingredient: Polygeline (3.5% Colloidal infusion solution of Polygeline with electrolytes for intravenous administration)
Affected counties: All
Affected Batch
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
HA3004
| 11/2023 | 10/2026 | 500 ml |
Brief description of the problem
The product is being recalled, following a complaint concerning bottle leakages and damage to mono cartons of Haemaccel 500mg Injection from hospitals, which was indicative of a potential breach of integrity.
Action for healthcare professionals
You are advised to immediately quarantine and stop supplying the remaining stocks of the impacted batches of the product. Galaxy Pharmaceutical Ltd will contact you to arrange for the return of the product.
Action for patients and caregivers
No further action is required by patients as this product is usually administered by healthcare professionals in a hospital setting, and the recall is a Retail/Hospital Pharmacy and Wholesaler/Distributor level recall.
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 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
- Mobile application: mPvERS both Android and iOS
For any further inquiries 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 Medicine Recall of Hemaccel (Polygeline) Injection, Batch Number HA3004