13 drugs recalled due to Vivozon's repeated GMP violations

Vivozon Pharmaceutical, which was punished for making drugs in unauthorized methods earlier this year, has been recently ordered to recall and discard medicines due to the same GMP violation.

The Ministry of Food and Drug Safety said on Monday that it would urgently request a recall of two medicines manufactured by Vivizon and 11 drugs made under the contract with Vivozon.

After inspecting the manufacturing site, the MFDS confirmed that Vivozon manufactured 13 drugs illegally.

Among the 13 drugs to be recalled, two are over-the-counter Vivozon’s Decorafen Tab. Sam Chun Dang Pharm’s S-bufen Tab., containing antipyretic and anti-inflammatory analgesic, dexibuprofen.

The other 11 prescription drugs are gastric ulcer treatments using rebamipide -- Rebadmi by Iksu Pharm, Rebaratin by Chong Kun Dang, Rebamigen by NewGen Pharm, Rebasco 100mg by Dasan Pharmaceutical, Rebapiron by Pharvis Korea, Rebis by Daewoo Pharmaceutical, Restam by Hana Pharm, Mucopro by DHP Korea, Mucopid by Shinpoong Pharm, Vivozon Rebapimipide 100mg by Vivozon Pharmaceutical, and Rebamiron by Yu & SK.

Out of the 13 drugs, 11 were ordered to be manufactured at a site other than Vivozon. An additional two -- Vivozon Rebapimipide 100mg and Rebamiron – were ordered to be recalled and suspended from sales.

The MFDS sent an urgent message to pharmaceutical and medical professionals to stop using the 13 drugs and use alternative medicines in patients who still needed the medication.

The regulator also noticed patients who recently received the drugs to consult with their doctor and take caution of side effects.

The administrative order to recall and discard the drugs was to prevent any mishap, the MFDS said.

As the MFDS had warned that it would show zero tolerance to companies that violate GMP regulations intentionally, it will likely take administrative and judicial actions against Vivozon.

Vivozon Group said, “We are investigating the situation regarding GMP violation.”