Ministry of Food and Drug Safety, “Unimed Osong Plant Ordered to Stop Production During Injection Manufacturing”

The two manufacturing numbers (200020, 200040) confirmed to be inadequate for quality (sterility test) in the'Unialju 15 mg (sodium hyaluronate)', an eye drop injection of UniMed Pharmaceutical, used as an adjuvant therapy for cataract surgery, were collected and The sale and use were suspended.  (Provided by KFDA)/Green Post Korea
The Ministry of Food and Drug Safety ordered Unimed Pharmaceutical’s Osong Plant to stop producing injections. (Provided by Unimed Pharmaceuticals)/Green Post Korea

[그린포스트코리아 이민선 기자] The Ministry of Food and Drug Safety ordered Unimed Pharmaceutical’s Osong Plant to stop producing injections.

The Ministry of Food and Drug Safety (Director Kang-rip Kim) checked Unimed Pharmaceuticals (located in Cheongju City, Chungcheongbuk-do) and confirmed that there is a possibility of microbial contamination throughout the injection manufacturing facility. It announced on the 24th that it has temporarily stopped manufacturing and sales (including prescription and use). In addition, for aseptic injections (three items), collection measures were taken for all serial numbers.

The five products produced in the manufacturing facility are Unialju 15mg, Hyalon Dispimp, Unilondispimp and Uniborn by UniMed Pharmaceutical. This includes Yuyu Pharm’s Mabil-Q stock, which is being manufactured by Unimed Pharmaceuticals.

This inspection was conducted on December 11, as it was confirmed that the quality (sterility test) of’Unialju 15 milligrams (sodium hyaluronate)’ was not suitable. Confirmed the possibility.

An official from the Ministry of Food and Drug Safety said, “The safety bulletin was distributed to doctors, pharmacists and consumers, etc., asking experts such as doctors and pharmacists to convert the product to other alternative medicines and to cooperate so that product collection can be performed properly. Through the Health Insurance Review and Assessment Service, we requested restrictions on prescriptions for the product in hospitals and clinics.”

On the other hand, if there are signs of abnormalities such as side effects that are suspected of being related to the product, you can immediately report it to the Korea Pharmaceutical Safety Management Agency.

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