[Alpha Biz= Paul Lee] Concerns are mounting after a recall was issued over the possibility that a different product was mixed into a hypertension drug sold by Daewoong Pharmaceutical, while the scale of contamination and the progress of the recall remain unclear more than a month later.

Preventing the mixing of different medicines during manufacturing is a fundamental principle of Good Manufacturing Practice (GMP). The incident has raised questions about whether Daewoong Pharmaceutical’s manufacturing processes are being properly controlled.

South Korea’s Ministry of Food and Drug Safety (MFDS) ordered a recall on March 7 of distributed batches of Olmetec Plus Tablets 20/12.5 mg, a combination hypertension drug sold by Daewoong Pharmaceutical, citing concerns that Olmetec Tablets 20 mg, a single-agent formulation, may have been mixed in.

Olmetec Plus contains 20 mg of olmesartan medoxomil and 12.5 mg of the diuretic hydrochlorothiazide, while Olmetec Tablets do not include the diuretic component. As a result, any mix-up could lead to patients receiving medication with a different composition than prescribed.

An MFDS official said, “Pharmaceutical manufacturing involves tablet production followed by bottle filling and labeling. In this case, we believe the issue most likely occurred during the bottle-filling stage.”

So far, Daewoong Pharmaceutical has confirmed contamination in 46 bottles but has not disclosed how many units have been recovered. The company also stated that it has yet to determine the full scope of potential contamination or the current status of the recall process.

Daewoong said it became aware of the issue after receiving complaints from pharmacies, submitted a recall plan to the MFDS on March 9, and sent notices to hospitals and pharmacies. However, consumer-facing communication has reportedly been limited to a notice posted on the company’s website, raising concerns that patients who were already prescribed and taking the medication may not have been promptly informed.

The Olmetec product line is a key revenue driver for Daewoong Pharmaceutical, accounting for approximately 2.3% of the company’s sales, or about ₩24 billion, on a cumulative basis through the third quarter of last year.

 

 

 

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