The Ministry of Food and Drug Safety is considering a one-month manufacturing suspension for Dong-A Pharmaceutical's children's fever reducer 'Champ Syrup,' which has shown browning in some products. On the 10th, the ministry announced that it is reviewing this administrative action because Dong-A Pharmaceutical failed to meet relevant standards during the customer complaint handling process regarding Champ.
Earlier, some products of Dong-A Pharmaceutical's children's cold medicine Champ Syrup exhibited browning, leading to a recall starting from the 5th. The recalled products have manufacturing numbers 2209031~2209040 and 2210041~2210046. The expiration dates of these products range from September 6, 2024, to October 24, 2024. So far, a total of 44 complaints related to browning of Champ have been received, with consumer complaints reportedly ongoing since January.
Dong-A Pharmaceutical explained that the browning phenomenon is believed to have occurred due to the product being exposed to heat during the drug distribution process. The sugars contained in the product have a characteristic of browning when exposed to high temperatures, and Dong-A Pharmaceutical estimates that this issue occurred during distribution and storage at the frontline.
The Ministry of Food and Drug Safety judges that Dong-A Pharmaceutical did not follow GMP (Good Manufacturing Practice) during the complaint handling process and is considering a one-month manufacturing suspension. This is because Dong-A Pharmaceutical neither clearly identified the cause of the browning phenomenon nor properly presented measures to prevent recurrence. According to GMP, pharmaceutical companies must promptly investigate complaints upon receipt, identify the cause, and establish measures to prevent recurrence.
An official from the ministry stated, "We are currently reviewing what kind of action to take while listening to the company's explanation," adding, "(Dong-A Pharmaceutical) did not conduct an accurate cause investigation nor prepare recurrence prevention measures."
On the other hand, Dong-A Pharmaceutical maintains that it is actively working on identifying the cause and preparing countermeasures. A Dong-A Pharmaceutical official said, "After the first customer complaint was received in January, we immediately recalled the product and began an investigation," adding, "As complaints increased, we held a Quality Management Committee meeting, decided on a voluntary recall, and promptly reported to the Ministry of Food and Drug Safety." The official further stated, "We have perfectly followed the procedures set by GMP and are strictly operating regulations related to customer complaint handling."
Dong-A Pharmaceutical plans to identify and improve issues in the product distribution process. The official emphasized, "We are preparing improvement measures related to distribution, but nothing has been decided yet," and added, "We will conduct a thorough investigation into this issue and establish recurrence prevention measures that will reassure customers."
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