Medicine Quality Alert: Class II Medicine Recall of Izzithree (Azithromycin) Suspension manufactured by Biopharma Ltd
Biopharma Ltd has initiated an urgent recall of Izithree (Azithromycin) Suspension, Batch No BPL 149A, BPL 068A and BPL 227A.
From: Pharmacy and Poisons Board
Published: 13th March 2024
Recall Reference Number: REC/2024/005
Recall Classification: Class II
Recall Level: Retail/Facility Level
Manufacturer: Biopharma Ltd
Product name: Izzithree Suspension
Active Pharmaceutical Ingredient: Azithromycin 200mg/5ml
Affected counties: All
Affected Batches
Batch Number | Date of Manufacture | Date of expiry | Pack Size |
BPL 149A | 07/23 | 06/26 | 15 ml |
BPL 068A | 06/23 | 05/26 | 15 ml |
BPL 227A | 08/23 | 07/26 | 15 ml |
Brief description of the problem
Biopharma Ltd is recalling batches BPL 149A, BPL 068A and BPL 227A, following market complaints of inadequate fill volume and therapeutic ineffectiveness. Further investigations by PPB revealed that there was also a color change.
Action for healthcare professionals
Quarantine all remaining stock and stop further distribution, sale, issuing, or use of the above batches immediately. Await contact from Biopharma Ltd to arrange 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 Izzithree Suspension.
Further Information
For inquiries on consignments of the impacted batches please contact Biopharma Ltd at: info@biopharmaltd.com or enderebakabera@gmail.com and by Telephone at +254 717 768 794
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, kindly contact the post-marketing surveillance unit of The Pharmacy and Poisons Board Kenya “the Board” via email at pms@ppb.go.ke
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Medicine Quality Alert: Class II Medicine Recall of Izzithree (Azithromycin) Suspension manufactured by Biopharma Ltd