Although a recall was ordered after concerns were raised that another product may have been mixed into an antihypertensive drug sold by Daewoong Pharmaceutical, it turned out that even the scale of the mix-up and the status of the recall had not been clearly identified a month later.
Preventing different drugs from mixing during manufacturing is the most basic principle of GMP (Good Manufacturing Practice). There are criticisms that Daewoong Pharmaceutical's manufacturing process is not being properly controlled.
The Ministery of Food and Drug Safety on Feb. 7 ordered a distributor recall of the antihypertensive combination drug Olmetec Plus 20/12.5 mg sold by Daewoong Pharmaceutical. The reason was concern that it may have been mixed with the single-agent antihypertensive Olmetec 20 mg.
Olmetec Plus contains 20 mg of the blood pressure–lowering agent olmesartan medoxomil and 12.5 mg of the diuretic ingredient hydrochlorothiazide together. In contrast, Olmetec does not contain a diuretic.
An official at the Ministery of Food and Drug Safety said, "The drug manufacturing process goes through tablet production, then bottle filling and labeling," and noted, "We see a high possibility that the problem occurred at the bottle-filling stage in this case."
So far, Daewoong Pharmaceutical has said it confirmed 46 bottles with the mix-up. It is not disclosing the quantity recovered. The company also said it still has not identified the potential additional scope of mixing or the progress of the recall effort.
Daewoong Pharmaceutical said it learned of the mix-up following a complaint report from a pharmacy and submitted a recall plan to the Ministery of Food and Drug Safety on Feb. 9, sending guidance letters to clinics, hospitals and pharmacies.
However, notices to general consumers were limited to a post on the company website, raising the possibility that patients who had already been prescribed and were taking the drug were not informed of the recall in a timely manner.
The Olmetec line is a key product group, accounting for 2.3% (about 24 billion won) of Daewoong Pharmaceutical's sales on a cumulative basis through the third quarter of last year.
Lee Gwang-min, vice president of the Korean Pharmaceutical Association, said, "From the perspective of a drug company, this is a serious management failure," adding, "This is an issue that should not occur in the manufacturing process."
Lee said, "Because antihypertensive drugs are typically prescribed in three- or six-month intervals, if a patient takes them without realizing it, blood pressure control could be affected."
However, Lee added that if the patient had been taking the medication long-term, they might have noticed something was off by checking the appearance (shape) and stopped taking it. Olmetec Plus is reddish-orange, and Olmetec is white.
Daewoong Pharmaceutical plans to complete the recall by Mar. 6. Under current rules, Class 2 and 3 risk drugs must be completed within 30 days after the start of the recall. However, if it is deemed difficult to complete within the period, an extension is possible with the local Ministery of Food and Drug Safety office head's approval after submitting a statement of reasons.
The Ministery of Food and Drug Safety classified this matter as risk Class 2. Class 2 is assigned when use of the drug may cause temporary or medically reversible health risks.
A Daewoong Pharmaceutical official explained, "We have to recall all products labeled with the relevant lot number, so the work is taking time," adding, "There are also many distributors, making the procedures complex." However, the company did not disclose the total quantity shipped or the number of transaction partners.
The company said this incident occurred due to a worker's error during the packaging process for the drug and described it as an individual, one-off mistake that appeared at a specific packaging stage for the item. It said other products and production lines were not affected.
It also said that, under internal rules, it convened a personnel committee to hold those involved and responsible to account and completed disciplinary measures. However, it did not disclose any separate additional plan regarding individual patient notifications.
According to the Ministery of Food and Drug Safety's Integrated Drug Information System, Daewoong Pharmaceutical has received a total of five drug recall orders since 2023 including this case. The reasons included mixing, detection of impurities and exceeding stability test standards. Including affiliate Daewoong Bio Co., the number rises to 11.
In 2024, some batches of the pediatric expectorant Eldos Syrup were classified as risk Class 2 after ingredients from another product were detected, and in September of the same year, the antifungal for nail athlete's foot Juplie External Solution was recalled after failing impurity standards.
With recall cases continuing for years, there is talk that on-site inspections by authorities may be strengthened. An official at the Ministery of Food and Drug Safety said, "The Daejeon regional office is conducting an investigation to determine the cause," adding, "We are looking into the entire manufacturing process, so it is hard to estimate the investigation period."