2023-08-10 05:03:57
On the 10th, the Ministry of Food and Drug Safety (Minister Oh Yoo-gyeong) lifted the ban on manufacturing and sales of Dong-A Pharmaceutical’s ‘Champ Syrup’ and Daewon Pharm’s ‘Col Daewon Kids Pen Syrup’.
The Ministry of Food and Drug Safety recommends recalling all manufacturing number products of ‘Champ Syrup’, which was confirmed to have browning and non-compliance with the microbial limit test in April and May, and ‘Coldaewon Kids Pen Syrup’, which had a phase separation phenomenon, and analyzed the cause and formulation Manufacturing and sales of the product were suspended until the improvement measures were completed.
Accordingly, each company completed the recall of the product, analyzed the cause of the problem and took measures to improve the formulation, and submitted the results and supporting data to the Ministry of Food and Drug Safety. It was decided to lift the ban on manufacturing and selling products.
‘Champ Syrup’ and ‘Cole Dae One Kids Pen Syrup’, which have been improved with the lifting of this measure, will start shipping from the factory immediately and will be distributed to pharmacies.
Dong-A Pharmaceutical confirmed that the browning of ‘Champ Syrup’ was caused by the browning reaction (caramelization reaction, Maillard reaction) of the sweetener contained in the product.
In addition, it was found that the detection of microorganisms exceeding the standard was caused by the proliferation of fungi (genus Pichia) caused by the D-sorbitol solution used as a sweetener due to the low preservative power of the product itself.
Pichia sorbitophila and Pichia anomala are known to exist in various fermented foods such as soybeans, soybean paste, beer, yeast, and wine, and are the first-class strains with the lowest risk among biosafety classes.
According to these investigation results, Dong-A Pharmaceutical stopped using the sweetener that caused the browning reaction and detection of excess fungi, added a preservative to the product, and added a heat treatment process to kill microorganisms during the manufacturing process.
Daewon Pharmaceutical analyzed that due to the low viscosity and density of ‘Cole Daewon Kids Pen Syrup’, the main ingredient settled down and separated into a clear transparent liquid phase and a white opaque liquid phase.
Daewon Pharmaceutical changed the amount of additives to improve this, and thus proved that the phases do not separate and remain stable.
The Ministry of Food and Drug Safety said, “We will continue to do our best to ensure that safer medicines are manufactured and distributed, considering public safety and safety as our top priority.”
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