Voluntary recall announced of Bayer's contrast agent 'Gastrografin'

CMG Pharm's Tratol Inj has been voluntarily recalled due to an excessive level of a nitrosamine byproduct

Operator recalls have been issued for Samchandang Pharm's S-Porin Eye Drops 0.05% and Jeil Pharmaceutical's Linatin Tab

Bayer Korea's Gastrografin

Bayer Korea's contrast agent Gastrografin (amidotrizoic acid, meglumine, sodium hydroxide) is being recalled for its commercially distributed units due to concerns over excessive impurity detection. Bayer has suspended supply in South Korea as a preemptive measure.

Gastrografin is a contrast agent used for gastrointestinal examinations, with an import value of $139,636 (KRW 206.18 million) as of 2024.

The Ministry of Food and Drug Safety (MFDS) announced on the 26th of last month that it issued an operator recall for commercially distributed units of certain batch numbers of Bayer Korea's Gastrografin due to concerns over the detection of the impurity N-Nitroso-Meglumine exceeding permissible limits.

The batch numbers subject to recall are MA04TPB, MA04RUS, MA04NK2, MA04NDM, MA04JX3, MA04H8X, MA048E7, MA043KK, MA040LT, and MA03VLL.

Bayer stated, "During recent post-marketing stability testing, the potential formation of N-Nitroso-Meglumine, a nitrosamine byproduct, was identified. While this component was not detected during quality testing at the shipping stage, post-marketing stability results for some manufacturing units confirmed levels exceeding the European Medicines Agency (EMA) Acceptable Daily Intake (ADI) standards (calculated based on conservative guidelines for nitrosamine byproduct management)."

The company added, "Bayer has decided to stop production immediately and voluntarily recall all manufacturing units currently in circulation (Class II) as a preemptive measure. Depending on clinical judgment, alternative use of broadly approved low-osmolality iodinated contrast agents is possible."

Furthermore, they explained, "The cause of the component's formation is under investigation, and production of new batches will be temporarily suspended until the investigation is complete. At this point, it is difficult to predict when the supply of Gastrografin will resume."

Additional products are being recalled due to excessive impurity levels. CMG Pharm's Tratol Inj (tramadol hydrochloride) has been recalled for batch numbers 23001, 23002, 23003, 24001, 24002, 24003, 24004, 24005, and 24006. The official announcement date was the 27th of last month.

Tratol Inj is used for severe and moderate acute or chronic pain (such as various cancers) and for pain following diagnosis and surgery. Its production performance in 2024 was 49.82 million KRW.

Meanwhile, certain units of Samchandang Pharm's S-Porin Eye Drops 0.05% (cyclosporine) are being voluntarily recalled following the discovery that the outer packaging and the contents differ.

The batch number for the recalled product is 25004. The production performance of this product in 2024 was KRW 1.2 billion. The recall was officially announced on the 27th of last month.

Additionally, Jeil Pharmaceutical's diabetes treatment, Linatin Tab (linagliptin), has been recalled voluntarily due to deviations from standards in certain categories (active ingredient content) during post-marketing stability testing. The MFDS announced this as of March 3.

The recalled batch numbers are FLEA601, FLEA602, FLEA603, FLEA701, FLEA702, FLEA703, FLEA704, FLEA705, and FLEA801. The production performance of this product in 2024 was KRW 651.16 million.