The government said it has banned the sale of Il-yang Pharmaceutical’s antianginal treatment Simgyeonglac Cap. and ordered the recall of the product, after detecting excessive lead.
The Ministry of Food and Drug Administration received a complaint that the drug contained too much lead. After collecting and inspecting the medicine, the government confirmed that the lead in the drug exceeded the standard level.
The ministry also ordered the discontinuation of use and recall of other drugs that contained the same ingredients, conducting additional investigations.
Simgyeonglac Cap. is an over-the-counter drug that Il-yang commissioned to Kyungjin Pharm for manufacturing.
Ingredients of the treatment include ginseng, hirudo (leech), scorpion, scolopendra corpus, cicadidae periostracum (cicada shell), peony root, eupolyphaga, and d-borneol. Among them, hirudo and cicadidae periostracum had more than 5ppm of lead, the ministry said.
The ministry has temporarily prohibited the distribution and sales of all Simgyeonglac products, except for those with manufacturing number 18001. The government will collect and inspect all the products and distribute only those deemed safe, it said.
The government also banned Miryung Herb Medicine’s production, distribution, and sales of Miryung hirudo and Miryung cicadidae periostracum, which were the causes of excessive lead in the Il-yang’s drug.
Miryung Herb Medicine was found to have manufactured the problematic ingredients at a site not certified by the GMP (Good Manufacturing Practice) standard. The ministry confirmed that the company falsely made manufacturing records and documents and ordered the firm not to produce, import, distribute, or sell any pharmaceutical product in Korea.
The ministry is investigating Il-yang, Kyungjin, and Miryung to find additional causes of excessive lead. “If we find any law violation, we will file a suit or give an administrative order,” the ministry said.
The ministry alerted consumers who have taken the medicine to stop using it. For inquiries about refund or return of the product, it advised them to contact Il-yang Pharm’s drug counseling office at 080-021-1010.
If consumers have any symptoms of vomiting, acute pain, stomach pain, headache, convulsions, or paralysis, they should immediately report to the Korea Medicines Safety Agency (Tel: 1644-6223, Fax: 02-2172-6701), the ministry noted.