Pfizer Korea recorded the largest number of drug recalls and disposals among multinational pharmaceutical companies in Korea last year, the health authorities said Wednesday.

The Ministry of Food and Drug Safety said the total number of drug recalls and disposals reached 128 in 2017. Twenty-eight were prescription drugs, eight were over-the-counter (OTC) drugs, and the rest, ingredients for traditional herbal medicine, medical device and agricultural pesticides.

Pfizer Korea recorded the most drug recalls and disposals among multinational pharmaceutical companies in Korea in 2017, according to the Ministry of Food and Drug Safety. Among local drugmakers, Ildong Pharm and CJ HealthCare had the most drug recalls.

Pfizer Korea recalled four lots of two drugs – three lots of dyslipidemia treatment Lipitor and two lots of anxiety drug Xamax – which were the most among drugmakers.

Pfizer Korea voluntarily recalled three lots of Lipitor 20mg and 40mg due to out-of-specification results in microbiological stability tests overseas. It also withdrew two lots of Xanax 0.25mg (ingredient: alprazolam) after discovering some empty bottles on sale and a possibility of deviation in a stability test.

Six other multinational drugmakers also had a drug recall at least once last year.

Sanofi-Aventis Korea voluntarily recalled Epidra Injection (ingredient: insulin glulisine) due to deviations in a stability test, and Kyowa Hakko Kirin Korea removed Mitomycin-C-Kyowa Injection 10mg from the market citing the need for more stability tests.

Abbott Korea withdrew Depakote Sprinkle Capsule due to a marking error in expiration date. Mundipharma Korea’s Bisphentin Controlled-Release Capsule 10mg also had a marking mistake in the secondary packaging. Janssen Korea recalled Leustatin Injection for a possible deviation in a stability test.

Among local drugmakers, two companies – Ildong Pharm and CJ HealthCare – had two drug recalls each. Others that had a single drug recall include JW Pharmaceutical, JW Shinyak, Ilsung Pharmaceuticals, Aprogen Pharmaceuticals, Boryung Pharmaceutical, Daehwa Pharmaceutical, Yooyoung Pharmaceutical, Dongkwang Pharm, and LG Chem.

Ildong Pharm was ordered to recall Ganamed Tab. after a discovery of a damaged tablet in the container. It also found abnormalities in colors or shapes of Belviq Tab.

CJ HealthCare recalled Kabalin Cap. for a marking error.

Boryung Pharm removed Cold Three Day & Night Soft Cap. from the market to identify the cause of a foreign substance, and JW Shinyak, Metapasone Gel because of different colors or shapes of the products. Yooyoung’s Artis F Tab. had an error in labeling and Daehwa Pharm’s Warfarin Tab. had incorrect numbers of tablets, leading to recalls.

Ilsung Pharmaceuticals withdrew Ilsung Augmentin Tab. due to a marking error and JW Pharmaceutical’s Clean-2 Solution failed a microbial limit test. Aprogen Pharmaceuticals recalled Albu Gold Soft Cap. after some products failed a disintegration test.

LG Chem’s IVF-M HP Injection 75IU did not have a problem in the safety and efficacy of the saline solution. However, the company voluntarily recalled it, after it found expiration date marking error on the outside of the packing box.

Besides the drugmakers, other firms that had a recall order were mostly manufacturers handling ingredients for traditional herbal medicine. Their products were unfit for sale because of issues in content, quality, cadmium level, and residual pesticide level.

sjh@docdocdoc.co.kr

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