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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:

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