Alvogen voluntarily recalls Comtan Tab due to impurities

Excess impurities detected in NDEA during post-marketing stability testing

Single-agent entacapones, which are used for Parkinson's syndrome, are being recalled due to the detection of excess impurities.

 

The issue of drug impurities continues to arise after MFDS has added nitrosamine impurity testing as a quality control test item to strengthen the management of nitrosamine impurities.

 

On March 30, MFDS announced the recall of Alvogen Korea's Comtan Tab 200mg (entacapone) due to the detection of excess NDEA in the post-market stability test.

 

In April, following the company's report that N-nitrosodiethylamine (NDEA) impurities were detected in its single agent entacapone, the MFDS began reviewing safety measures, including setting necessary temporary permissible standards based on the submitted test and inspection results.

 

The MFD introduced the Carcinogenic Potency Categorization Approach (CPCA), which predicts carcinogenic potential based on the structure-activity correlation of molecules, to set standards for nitrosamine impurities as introduced by the European EMA and the U.S.

 

FDA, and updated the daily intake allowance for nitrosamine impurities in Korea based on the standard-setting method.

 

However, in the case of medicines with medical necessity or supply interruption (shortage), a temporary distribution allowance is applied for a certain period of time to address the supply and demand situation.

 

The item being recalled this time is Comtan Tab 200mg with the lot number (expiration date) '2169627 (2026-07-30).’ Currently, there are only 2 items licensed in Korea as single-agent entacapone: Comtan Tab 200 mg and Myungin Entacapone Tab 200mg by Myung In Pharmaceutical.

 

Single-agent entacapone is indicated as an adjunct to levodopa-dopa decarboxylase inhibitors in patients with Parkinson's syndrome whose symptoms do not improve with standard levodopa-dopa decarboxylase inhibitors therapy.