Huons is voluntarily recalling three products in the United States, including the local anesthetic injection lidocaine.
Huons said on the 20th that it recently reported a voluntary recall to the U.S. Food and Drug Administration (FDA) for lidocaine injection, bupivacaine hydrochloride injection, and 0.9% sodium chloride injection.
A Huons official said, "The recall amounts to $3.5 million (about 5.2 billion won)," and noted, "There is no issue with product quality."
Huons produces lidocaine and other products for export to the United States at its Jecheon plant in North Chungcheong Province. However, the company said that in the process, certain data system operations were found to fall short of the FDA's current good manufacturing practice (cGMP) standards for drugs.
Huons has focused on the United States, the world's largest pharmaceutical market. It exports seven products, including lidocaine, to the United States. However, three products are currently temporarily halted at customs due to the voluntary recall. A Huons official said, "After submitting a corrective action report, we plan to ask the FDA to lift the customs hold."