MFDS Orders Dong-A to Stop Using 'Champ Syrup'

The Ministry of Food and Drug Safety (MFDS) recently decided to halt the manufacturing, sales, and use of the entire batch of Dong-A Pharmaceutical's children's fever reducer "Champ Syrup" (active ingredient acetaminophen) after issues related to microbial contamination surfaced, following voluntary recalls due to browning phenomena.

Children's fever reducer 'Champ Syrup (Acetaminophen)' by Dong-A Pharmaceutical [Photo by Dong-A Pharmaceutical]

On the 25th, the MFDS announced that it has mandated a "forced recall" for two manufacturing lot numbers of the product where microbial limit issues were confirmed, while strongly recommending a "voluntary recall" for the remaining products. Additionally, the MFDS has temporarily suspended manufacturing and sales, and issued a "Drug Safety Alert" advising medical professionals and consumers to stop using the product and switch to alternative medicines.

Champ Syrup had been undergoing voluntary recalls by Dong-A Pharmaceutical after consumer complaints reported browning in some products. However, during the MFDS investigation, aside from the browning and other physical issues found in some lot numbers, microbial contamination exceeding acceptable limits was detected, leading to a recall of the entire product line.

An MFDS official explained, "(For the affected lot numbers) microbial test results during inspection were deemed non-compliant," adding, "Considering the need for a comprehensive root cause analysis, it was decided to recall all products and review their suitability as well as the adequacy of manufacturing and quality control." The investigation into the cause of browning is still ongoing separately.

Since Champ Syrup is a 'non-sterile formulation' syrup rather than an aseptic injectable, a certain level of microbial presence is permitted. However, during testing, fungi such as yeast and mold were detected beyond the acceptable limits, prompting the full recall. The MFDS also noted that pathogenic microbes with high disease risk, such as Escherichia coli and Salmonella, were not detected.

The temporary suspension of manufacturing, sales, and use will remain in effect until the appropriateness of Dong-A Pharmaceutical's manufacturing and quality control is confirmed. Currently, the MFDS is also collecting and testing other batches of Champ Syrup. Furthermore, Dong-A Pharmaceutical has been instructed to have all manufacturing lot products tested at MFDS-designated laboratories and to submit the results.

Consumers who have already purchased Champ Syrup can return the product and receive a refund at pharmacies. Refund applications are also available through Dong-A Pharmaceutical’s official website.

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