The Ministry of Food and Drug Safety (MFDS) issued an executive order to stop importing antibiotic KLARICID Dry Syrup (ingredient name: clarithromycin) 250mg/5ml for one month and 22 days. It revealed the order in the homepage on the 2nd.
It ordered to stop selling and to recall KLARICID Dry Syrup in 2016 because an alien substance was detected. After that, because the company didn’t take follow up measures, MFDS issued the order.
KLARICID Dry Syrup is used to treat inflammation in the upper and lower airways, acute otitis media, and skin inflammation etc. It is mostly used for children and dispensed as syrup.
A pharmacist found an alien substance when dispensing KLARICID Dry Syrup and reported it to Abbott Korea and MFDS. Abbott Korea investigated it and found the metal in the product with the same manufacture’s serial number of ‘6057795’. By the way, all the products that have the manufacture’s serial number ‘6057795’ were only imported to Korea.
MFDS ordered to stop selling and recall the product on May 2016 and took an action to temporarily stop selling and use another KLARICID Dry Syrup with different manufacture’s serial number as a preventive measure. It decided to suspend insurance coverage for the product from May to October in 2016.
MFDS issued the order to stop importing because Abbott Korea didn’t do quality inspection properly and the recall rate was low. After the order, Abbott Korea can’t import KLARICID Dry Syrup 250mg/5ml from 1st February to 22nd March.
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