엔시트라정(트라마돌염산염|아세트아미노펜)
Recall Summary Encitra tablets (containing tramadol hydrochloride and acetaminophen) manufactured by Hallim Pharmaceutical are being recalled in South Korea due to potential excess levels of an impurity called N-nitroso-desmethyl-tramadol. This is a precautionary measure affecting products with the specified barcodes that are currently in distribution. The recall is classified as Class II.
- Recalling firm
- 한림제약(주)
- Product
- 엔시트라정(트라마돌염산염|아세트아미노펜) (Barcode: 8806453011806, 8806453011813, 8806453011820, 8806453011837)
- Reason
- 불순물(N-nitroso-desmethyl-tramadol)초과검출우려에따른사전예방적조치로시중유통품에대한영업자회수
- Classification
- Class II
- Category
- drug recall
- Country
- South Korea
- Agency
- MFDS-DRUG
- Recall date
- 2026-04-02
- Status
- Ongoing
- Distribution
- South Korea
Official recall notice from MFDS-DRUG
Recall details on Nibble Recalls: https://trynibble.app/recalls/9b23fb55-65e5-44b6-93b1-b8e0942f07cc