The Board of Directors of KOTRA wishes to announce that Kotra Pharma (M) Sdn. Bhd., a wholly-owned subsidiary of KOTRA, will make a press announcement via The Star and Berita Harian on 29th December 2020 regarding a voluntary product recall for Axcel Mometasone 0.05% w/w Nasal Spray manufactured under batch numbers B1912005, B1912030, B1912038 and B1912050.
These batches mentioned are being recalled as they may not have met the Pharmacopeia microbial specifications. They were distributed in Malaysia through selected distribution points such as pharmacies, clinics and hospitals.
All the other batches have been retested and found to comply with Pharmacopeia Standard for safety and efficacy. We did not receive any adverse report on the use of these affected products.
We will implement the required preventive measures to avoid future recurrence.
The above recall does not have any significant impact to the financial performance or financial position of the Group for the year ending 30 June 2021.
This Announcement is dated 28 December 2020.