Dongkwang Pharm failed to promptly carry out necessary measures such as suspending sales during the recall of a prescription drug and received a penalty surcharge of around 170 million won from the Ministery of Food and Drug Safety.
According to the Ministery of Food and Drug Safety on the 12th, Dongkwang Pharm on the 28th received a penalty surcharge of 174.6 million won in lieu of a three-month suspension of manufacturing for "Triamcinolone Injection 40 mg (triamcinolone acetonide)."
Triamcinolone Injection 40 mg is an adrenocortical hormone (steroid) prescription drug used to relieve symptoms of allergic and inflammatory diseases and arthritis.
The Ministery of Food and Drug Safety determined that Dongkwang Pharm did not properly fulfill its obligation to immediately suspend sales and initiate necessary recall measures for products suspected of being subject to recall.
This sanction is an administrative disposition for violating recall procedures rather than for the product's quality itself. Earlier, in Mar., the Ministery of Food and Drug Safety ordered a business recall for certain lot numbers (MTR4E027) of the item after confirming concern over foreign matter contamination. It then examined whether initial response measures such as suspending sales were appropriate.
Under the Pharmaceutical Affairs Act and the Rules on Safety of Drugs, etc., a drug marketing authorization holder must immediately suspend sales and initiate recall measures if a product is suspected of being subject to recall. Violations of these obligations may be subject to administrative dispositions under the Pharmaceutical Affairs Act.