[Reporter's view] There should be no recurrence of the Champ

and Coldaewon Kidsfen Syrup incident

On the 10th, the Ministry of Food and Drug Safety lifted the suspension of manufacturing and sales of Dong-A Pharmaceutical's Champ Syrup and Daewon Pharmaceutical's Coldaewon Kidsfen Syrup.

 

Champ Syrup, which represents children's antipyretics containing acetaminophen, was produced and distributed again in 128 days, and Coldaewon Kidsfen Syrup in 85 days.

 

Dong-A issued a recall order four times on April 25th, April 28th, and May 31st, starting with the recall of commercially distributed products due to 'concern about unsuitable quality (characteristics, microbial limit) on April 4th.

 

On the other hand, Daewon Pharmaceutical recalled business operators for commercially available products as a precautionary measure following the phase separation phenomenon (concern) on May 18.

 

Although the reasons for the recall of the two items are different, it is unknown when and how the order to recall and destroy the drug will occur.

 

First, Champ Syrup, which had been recalled, went through the return and refund process through pharmacies and online.

 

In addition, when a customer brings a product to a pharmacy, even in the case of products purchased at other pharmacies, normal product exchange or return and refund measures are to be carried out first.

 

Suffering from the Champ Syrup recall process became the pharmacy distributing the product.

 

Perhaps for this reason, Daewon Pharmaceutical, which was advised to recall the business operator, went through the process of returning and refunding the drug directly to the pharmaceutical company without going through the pharmacy.

 

Of course, there was also Coldaewon Kidsfen Syrup, which was confused with Champ Syrup and brought to pharmacies, but pharmacies did not have to accept the product.

 

Champ Syrup and Coldaewon Kidsfen Syrup, which had been discontinued for nearly three months, were canceled at the same time, and it was the pharmacy that was confused again.

 

This is because it was not easy to order antipyretics for children whose production was resumed due to sales at specific hours and restrictions on the number of purchases per pharmacy.

 

As Champ Syrup and Coldaewon Kidsfen Syrup went through a series of incidents such as manufacturing, suspension, and cancellation, pharmaceutical companies were insufficiently prepared to resume distribution due to inconsistent recall procedures and the Ministry of Food and Drug Safety's unilateral cancellation of manufacturing/suspension.

 

Looking at this process, there is a need for support measures such as preparing a consistent procedure for recalls of business operators rather than compulsory recalls in the future and providing time to prepare for preparations such as pre-announcement by pharmaceutical companies in case of the lifting of manufacturing or suspension of drugs with issues such as supply and demand instability.

 

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