MFDS: "Ildong Pharmaceutical Recalls Depression Treatment Drug Due to Excessive Impurities"

The Ministry of Food and Drug Safety (MFDS) announced on the 28th that it is conducting a recall of Idong Pharmaceutical's depression treatment drugs "Dulox Tablets 30 mg" and "Dulox Tablets 60 mg (active ingredient: duloxetine hydrochloride)" due to the detection of impurities exceeding the allowable limits.

These drugs are white prescription medications used to treat depression, generalized anxiety disorder, diabetic peripheral neuropathic pain, and other conditions. The detected impurity is "N-nitroso-duloxetine," a type of nitrosamine known as a potential carcinogen. However, the MFDS stated that the carcinogenicity of individual impurities should be comprehensively assessed based on toxicity data from human and animal studies. A representative from Idong Pharmaceutical explained, "It is presumed that nitrosamine impurities were generated during the chemical synthesis process of the drug."

The recalled products include Dulox Tablets 30 mg with batch numbers HTA001, HTA003, HTA004, HTA005, HTB001, and HTB002, according to the company. The expiration dates are July 4 of this year, February 18 of next year, February 18, April 6, August 8, and August 8, respectively. For Dulox Tablets 60 mg, the recalled product is the batch number HSA001 with an expiration date of July 4 of this year.

Earlier, in February, the MFDS also recalled Alvogen Korea's diabetes treatment drug "Zensiga S Tablets" and other products with the same ingredient and dosage manufactured at the same factory, including Kyungbo Pharmaceutical's "Janustin Duo Tablets" and Korea Hutex Pharmaceutical's "Nanudang Siga Tablets," due to excessive detection of the nitrosamine compound "NTTP."