Dong-A, Daewon resume sales of suspended children's cold medicines

Children's cold medicines suspended due to quality control issues are back on the market after improvements.

The Ministry of Food and Drug Safety said Thursday that it had lifted the suspension of manufacturing and sales of Dong-A Pharmaceutical's Champ Syrup and Daewon Pharmaceutical's Coldaewon Kids Pen Syrup.

This past April, the ministry recommended the recall of Champ Syrup, which was found to have browning and non-compliance with microbial limit tests. The following month, it found the phase separation of Coldaewon Kids Pen Syrup and recommended the same step.

It then suspended the manufacture and sale of the entire product until the cause analysis and formulation improvement measures were completed.

In response, each company completed the recall of the affected products, analyzed the cause of the problem, implemented measures to improve the formulation, and submitted the results and supporting data to the ministry. The regulator reviewed them closely, deemed them valid, and decided to lift the suspension of manufacturing and sales of the products.

The improved Champ Syrup and Coldaewon Kids Pen Syrup will immediately begin shipment from the factory for distribution to pharmacies.

It was confirmed that the browning of Dong-A's Champ Syrup was caused by the sweetener in the product, causing a browning reaction (caramelization reaction, Maillard reaction). In addition, the detection of microorganisms exceeding the standard was caused by the fungus (Pichia spp.) originating from the D-sorbitol solution used as a sweetener multiplying due to the low preservation power of the product.

Fungi of the genus Pichia are known to be present in various fermented foods such as soybeans, bean paste, beer, koji, and wine. They are classified as Class 1 strains, the least hazardous of the biosafety classes.

Based on these findings, Dong-A stopped using the sweetener that caused the browning reaction and excessive detection of fungi, added a preservative to the product, and added a heat treatment process to kill microorganisms during manufacturing.

Daewon Pharm analyzed that the low viscosity and density of Coldaewon Kids Pen Syrup caused the main ingredient to settle down and separate into a clear transparent liquid and a white opaque liquid, called the “phase separation” phenomenon. Daewon changed the amount of additives to improve this problem and proved that the phase did not separate and remained stable.

"We will continue to do our best to ensure that safer drugs are manufactured and distributed, considering public peace of mind and safety as our top priority," the ministry said.