The Ministry of Food and Drug Safety has decided to temporarily suspend the manufacturing and sales of Daewon Pharmaceutical's 'Col Daewon Kids Pen Syrup,' which exhibited a 'phase separation' phenomenon.
On the 17th, the Ministry announced that it recommended Daewon Pharmaceutical to voluntarily recall all remaining batches within the expiration date of Danagen's 'FineQ Acetaminophen Syrup,' which is contract-manufactured by Daewon Pharmaceutical using the same manufacturing method as Col Daewon Kids Pen Syrup, and has also taken temporary manufacturing and sales suspension measures.
The Ministry explained that this action was taken after confirming the phase separation phenomenon in Col Daewon Kids Pen Syrup and after conducting inspections on manufacturers and importers producing liquid syrups and suspensions containing 'acetaminophen,' including the product in question, as well as consulting experts and synthesizing the results.
However, the Ministry stated that no violations were found in Daewon Pharmaceutical's manufacturing process or quality control procedures. It also added that no phase separation phenomenon was observed in other domestically distributed liquid syrups and suspensions. Regarding the phase separation phenomenon itself, expert consultation results indicated that "phase separation can occur due to the nature of suspensions" and that "the actual risk is low even when phase-separated products are divided and consumed."
Nevertheless, experts expressed the opinion that "when phase-separated products are divided and consumed, the amount of the active ingredient administered may be somewhat less or more," and "measures are needed to ensure product uniformity through formulation improvements," the Ministry reported. In other words, although the actual risk is low and the phenomenon can sufficiently occur due to the nature of the formulation, there is still some risk, so improvement measures by the manufacturer are necessary.
Accordingly, the Ministry recommended a voluntary recall by the company as a preventive measure for Col Daewon Kids Pen Syrup and FineQ Acetaminophen Syrup, suspended manufacturing and sales, and ordered the improvement of the formulations of these products. The Ministry added that this measure will remain in place until Daewon Pharmaceutical confirms formulation improvements and other measures, and that additional necessary safety measures will be implemented in the future.
It also requested that any adverse reactions or abnormal signs suspected to be related to these products be reported immediately to the Korea Institute of Drug Safety & Risk Management.
Daewon Pharmaceutical and Danagen plan to accept returns and provide refunds for products held by consumers. A Daewon Pharmaceutical official stated, "We will proceed with the recall according to the Ministry's measures and do our best to present improved products with formulation enhancements as soon as possible."
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