From Self-Test Kits to Cold Medicine... Ongoing Quality Controversies

SD Biosensor detects tear fluid contamination in US export kits
Dong-A Pharmaceutical finds excessive fungi in children's cold medicine

Daewon Pharmaceutical faces suspension separation suspicion in suspension
"Natural phenomenon, no problem"

The self-test kit and cold medicine industries, which rapidly grew during the COVID-19 pandemic, are now suffering from sudden quality controversies. Regulatory authorities are demanding product disposal or manufacturing suspension due to contamination or excessive microbial detection, creating a chain of nightmares.

SD Biosensor's COVID-19 self-test kit 'Pilot COVID-19'
[Photo by Roche Diagnostics]

According to the related industry on the 9th, the U.S. Food and Drug Administration (FDA) recently recommended that SD Biosensor dispose of some products of the COVID-19 self-test kit "Pilot COVID-19" sold in the U.S. due to bacterial contamination. Pilot COVID-19 received Emergency Use Authorization (EUA) from the FDA in 2021 and has been supplied to the U.S. through the global medical device company Roche Diagnostics. Since it was approved by the Korean Ministry of Food and Drug Safety (MFDS) only for export, all units are exported and not sold domestically.

The FDA warned healthcare professionals and consumers to stop using products from a total of 44 lot numbers due to concerns that the reagent might be contaminated with bacteria. Furthermore, it cautioned that direct contact with the reagent could pose safety concerns for immunocompromised individuals and advised seeking medical attention if symptoms such as fever or conjunctivitis appear after contact. The FDA also added that testing with contaminated reagents could result in false positive or false negative results. SD Biosensor and Roche Diagnostics are conducting voluntary recalls of the affected lot number products.

Such quality controversies involving domestic pharmaceutical and bio companies have recently occurred repeatedly. Quality issues have also arisen in children's cold medicines produced by Dong-A Pharmaceutical and Daewon Pharmaceutical, prompting the MFDS to initiate investigations or ban product distribution.

Dong-A Pharmaceutical's children's antipyretic "Champ Syrup" (active ingredient acetaminophen) has had its manufacturing and sales suspended by the MFDS. Last month, consumer complaints about browning in some products led Dong-A Pharmaceutical to conduct voluntary recalls of certain batches. However, during the MFDS investigation, microbial contamination exceeding limits was found in some products in addition to browning, resulting in a recall of the entire product line.

Champ Syrup is a 'non-sterile preparation' syrup, not an aseptic injection, so a certain level of microbial detection is permitted. However, during testing, fungi such as yeast and mold were detected beyond acceptable limits, leading to the full recall. The MFDS added that pathogenic microbes with high disease risk, such as Escherichia coli and Salmonella, were not detected.

An MFDS official explained, "(The affected manufacturing numbers) were judged non-compliant in microbial testing during the inspection process," adding, "After determining that a comprehensive cause analysis is necessary, the entire product was recalled to review product suitability and the appropriateness of manufacturing and quality control." The investigation into the cause of browning is still ongoing separately.

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

However, the quality controversy is not limited to Champ Syrup but continues with children's cold medicines. Recently, an online community raised suspicions of 'phase separation' in Daewon Pharmaceutical's "Coldaewon Kids Pen Syrup" (active ingredient acetaminophen). The claim is that acetaminophen and syrup additives are excessively clumped separately, and if the medicine is divided for consumption, there is a risk of overdosing.

However, some point out that for Coldaewon, this is a natural phenomenon due to the characteristics of 'suspension' products, and excessive concern is being raised. A representative from another suspension medicine manufacturer said, "Suspension syrups are designed to make ingredients that are hard to mix easier to take, so phase separation can naturally occur," adding, "Even if divided, shaking well before use is fine, but some are causing unnecessary anxiety."

In fact, the MFDS, which started an investigation following related concerns, explained that suspensions should be "well shaken and homogenized as needed before use." A Daewon Pharmaceutical representative said, "We are thoroughly managing quality and only shipping products that have passed suitability tests," adding, "We are awaiting the MFDS results."