ISO 9001: 2015: CERTIFIED

PUBLIC NOTICE

RECALL OF SUBSTANDARD BATCHES OF XSONE N EYE/EAR DROPS FROM THE MARKET

1. The Tanzania Medicines and Medical Devices Authority (TMDA) would like to alert the public that it has ordered for recall two batches of product namely Xsone N (Sodium Phosphate 0.1% w/v and Neomycin Sulphate 0.35% w/v) 5ml, eye/ear drops manufactured by Abacus Parenteral Drugs Limited of Kampala, Uganda.
2. This alert comes after a notification for voluntary recall of substandard batches of the above named product.
3. The two batches of the product (i.e batch number 69E00123 manufactured in May 2023 and expiring in October, 2025 and 69D02323 manufactured in April, 2023 and expiring in September, 2025) have been confirmed to contain brownish spot at the bottom of the vials. The approved vials contain clear and sterile aqueous solution.
4. Through this notice the general public is directed to stop using the concerned product and dealers should return the same to their suppliers.
5. The TMDA continues to oversee and monitor the recall process pursuant to the existing regulations.
6. The public is further urged to report to TMDA any suspected substandard product from the martket.
7. Together we can protect and promote public health