Kotra recalls four batches of Axcel Mometasone Nasal Spray

TheEdge Mon, Dec 28, 2020 07:13pm - 1 month ago


KUALA LUMPUR (Dec 28): Kotra Industries Bhd's wholly-owned unit Kotra Pharma (M) Sdn Bhd has announced voluntary product recall for Axcel Mometasone 0.05% w/w Nasal Spray as it "may not have met the Pharmacopeia microbial specifications", said the pharmaceutical firm.

Kotra said in a filing with the stock exchange that the voluntary recall for this particular product is only for those that were manufactured under batch numbers B1912005, B1912030, B1912038 and B1912050.

"They were distributed in Malaysia through selected distribution points such as pharmacies, clinics and hospitals," said Kotra.

All the other batches, on the other hand, 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," said Kotra.

Kotra noted that the said recall does not have any significant impact on the group's financial performance or financial position for the year ending June 30, 2021.

Shares of Kotra closed unchanged at RM3.01, valuing the company at RM445.28 million. Year-to-date, the stock has gained 60% from RM1.88.






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