The Ministry of Food and Drug Safety has suspended the sale of Novartis Korea’s Pataday 0.2 percent Eye Drops, a conjunctivitis treatment, until Dec. 22.
The administrative penalty came after the regulator found that the company labeled the period of the use in the second packaging of Pataday (ingredient: olopatadine) differently from the authorized one.
Pataday 0.2 percent Eye Drops treat allergic conjunctivitis and patients can apply it once daily.
According to the rules of administrative punishment for the safety of medicines, the authorities can punish companies that label the following items differently from authorized versions: Name and address of the company that received the drug approval or the importer of the licensed drug (in case of consignment manufacturing, the name and address of manufacture), product name, manufacturing number and expiration date, name of all ingredients displayed on the permit and the registration card, amount of active ingredient, amount of preservative, dosage and precautions for use, appearance, efficacy, and storage method.
The breach of any items above the first time is subject to a three-month suspension of the sale of the product, the violation for the second time, suspension of the sale for six months, and that for the third time, revocation of the product license.