Hyundai Pharm Mistakenly Placed Dementia Medication in Hypertension Pill Bottle Labeled 'Such a Mistake'

Alzheimer's Dementia Drug 'Tamirin Tablets' Distributed in Containers Labeled for Hair Loss Medication 'Minoxidil'
Approximately 20,000 Bottles Recalled

Hyundai Pharm has been found to have distributed Alzheimer's dementia treatment drugs in the containers of hypertension medication, leading to a recall.

According to the Ministry of Food and Drug Safety (MFDS) on the 1st, on the 23rd of last month, the MFDS ordered Hyundai Pharm to recall Hyundai Minoxidil Tablets (active ingredient: Minoxidil) with the manufacturing number 23018, produced on the 15th of last month. The MFDS explained the reason for the recall as "a business operator recall due to some labeling of other products being attached to the packaging container."

Minoxidil is a drug used for treating hypertension and hair loss. The oral tablets (5 mg) have a vasodilatory effect and are used as hypertension treatment, while 2-5% topical solutions promote hair growth and are used for hair loss treatment. The issue in this case concerns the oral tablets. Although it has a strong vasodilatory effect that lowers blood pressure, it has side effects such as congestive heart failure and tachycardia. Therefore, it is almost a last-resort option used only for severe hypertension, such as hypertension caused by long-term organ damage or refractory hypertension that does not respond even to the maximum dose of other blood pressure medications. However, it is known that some medical institutions in Korea use it off-label for hair loss treatment.

Image information of this batch's discarded items [Image source=Uiyakpum Anjeon Nara]

However, it was confirmed that Hyundai Pharm placed a completely different ingredient, the Alzheimer's dementia treatment drug 'Tamirin Tablets (Galantamine),' into the Minoxidil tablet containers during the factory production process. Tamirin Tablets are prescription drugs produced by Hyundai Pharm used for mild to moderate Alzheimer's-type dementia symptoms. The two drugs use containers of the same size and shape, and both drugs are white tablets with a diameter of 6.5 mm, making them difficult to distinguish visually except for the engraved active ingredient name, which appears to have caused the mix-up.

Upon confirming this fact, Hyundai Pharm initiated an urgent recall. Through its website and other channels, it announced a "public notice regarding drug recall," stating, "Pharmaceutical distributors, pharmacies, and medical institutions that have these drugs in stock should immediately stop sales and return them to the recall obligor (Hyundai Pharm)." It is reported that approximately 20,000 bottles are subject to this recall.

The risk level of this recall was evaluated as Grade 1. The risk levels are divided into Grades 1 to 3, with Grade 1 indicating issues with drug safety and efficacy that are directly life-threatening. This includes ▲cases where the use of the drug causes incurable serious side effects or death, ▲cases where fatal ingredients are mixed in, and ▲cases where incorrect labeling on the drug could affect life. However, it is known that no consumers have mistakenly taken the drug due to this manufacturing issue so far.