Shortage of Children's Fever Reducers to Ease... Sales Suspension Lifted for Top 1~2 Brands Champ and Coldawon

The Ministry of Food and Drug Safety announced on the 10th that it has lifted the manufacturing and sales suspension orders on Dong-A Pharmaceutical's ‘Champ Syrup’ and Daewon Pharmaceutical's ‘Col Daewon Kids Pen Syrup.’

Dong-A Pharmaceutical Champ Syrup

The Ministry had previously imposed manufacturing and sales suspension orders on all products of ‘Champ Syrup,’ which showed browning phenomena, and ‘Col Daewon Kids Pen Syrup,’ which exhibited phase separation, during April and May. These measures were to remain in place until the causes were analyzed and formulation improvements were completed. The companies conducted recalls of the affected products and submitted the results of the cause analysis, improvement measures, and supporting evidence to the Ministry. After reviewing these submissions, the Ministry deemed them valid and lifted the suspension orders on the products.

According to the Ministry, the browning phenomenon in Dong-A Pharmaceutical’s Champ Syrup was caused by caramelization and Maillard reactions triggered by sweeteners contained in the product. Furthermore, the detection of microorganisms exceeding standards was traced to fungi originating from Indian-made D-sorbitol solution used as a sweetener, which proliferated due to the product’s low preservative capacity.

Accordingly, Dong-A Pharmaceutical ceased the use of the sweetener responsible for the browning reaction and fungal overgrowth, added preservatives to the product, and introduced a heat treatment process during manufacturing to eliminate microorganisms, the Ministry explained.

In the case of Daewon Pharmaceutical’s ‘Col Daewon Kids Pen Syrup,’ the phenomenon of phase separation into a clear transparent liquid and a white opaque liquid was found to be caused by the main ingredient settling downward due to low viscosity and density. Daewon Pharmaceutical adjusted the amount of additives and demonstrated that the product remained stable without phase separation, the Ministry reported. A Ministry official stated, “With the lifting of this measure, the improved products will immediately begin shipping from the factories and be distributed to pharmacies.”

As these products, which hold the majority market share in the children’s antipyretic (fever reducer) market, have had their sales suspension lifted, the shortage of antipyretics is expected to be resolved quickly. Parents with young children had been struggling to find syrup-type antipyretics at pharmacies.

A representative from Dong-A Pharmaceutical said, “We will take this incident as a lesson to strengthen safety and quality verification systems in quality management to prevent recurrence and produce excellent pharmaceuticals to restore consumer trust.” They emphasized, “Following the Ministry’s measures, we will produce the improved products as quickly as possible to resolve the antipyretic shortage.”

This content was produced with the assistance of AI translation services.