Kwangdong Pharmaceutical Completes Voluntary Recall and Discontinuation of 'Amitapiju'... Will Strengthen Management of Contract-Manufactured Drugs

[Asia Economy Reporter Lee Gwan-joo] Kwangdong Pharmaceutical announced on the 5th that it has voluntarily recalled the amino acid supply injection 'Amitapi-ju,' which received a three-month manufacturing suspension administrative sanction from the Ministry of Food and Drug Safety, starting from December last year, and the recall has been completed. The product is currently discontinued.

Amitapi-ju, which Kwangdong Pharmaceutical had commissioned Samsung Pharmaceutical to produce, was found to have an inappropriate content of 'acetylcysteine' in its ingredients last year, after which a recall plan was submitted to the Ministry of Food and Drug Safety. The voluntary recall process was completed on February 17 of this year.

A Kwangdong Pharmaceutical official explained, "The product has been fully recalled and disposed of, so it is no longer available on the market," adding, "We have changed the manufacturer and are distributing a new product, and we are also strengthening the management of commissioned companies."

Furthermore, Kwangdong Pharmaceutical is currently supplying 'Amitapi-baekju' and is operating a stricter management system for commissioned companies by expanding supplier evaluation and monitoring and reinforcing evaluation criteria. A Kwangdong Pharmaceutical official stated, "We will faithfully comply with the Ministry of Food and Drug Safety's sanctions and strive to prevent recurrence in the future."

This content was produced with the assistance of AI translation services.