The Pharmaceutical Supervision and Administration Bureau (ISAF) recalled yesterday a number of batches of a Spanish-made contrast agent* as it contains impurities.
According to a notification by a local pharmaceutical products importer, the bureau has been informed that certain batches of the contrast medium Gastrografin Liq Oral/Rectal, manufactured by BerliMed in Spain, was found to contain levels of the impurity N-Nitroso-Meglumine** exceeding acceptable limits.
As a precautionary measure, the bureau said, the manufacturer has voluntarily recalled four batches of the product exported to Macau.
The affected batches are MA04HF2, MA04MPR, MA04P3R, and MA04S8L.
According to the statement, the product is a prescription drug used for gastrointestinal examinations.
Based on information provided by the importer, the affected batches were supplied to the public Conde de São Januário Hospital Centre (CHCSJ), the Islands Healthcare Complex – Macao Medical Centre of Peking Union Medical College Hospital (PUMCH), and several private hospitals in Macau, the statement said.
The Pharmaceutical Supervision and Administration Bureau has instructed the importer to proceed with the recall and has requested medical institutions immediately to cease using the affected batches.
*A contrast agent (or contrast medium) is considered a type of medication used in medical imaging procedures. These agents enhance the visibility of internal structures in imaging modalities such as X-rays, CT scans, and MRIs. – Poe
**N-Nitroso-Meglumine is a chemical compound that belongs to a class of organic compounds known as nitrosamines, a sugar alcohol used as a pharmaceutical excipient. Exposure to nitrosamines can potentially increase the risk of various types of cancer, including gastric and oesophageal cancers in humans. – Poe
This undated handout photo provided by the Pharmaceutical Supervision and Administration Bureau (ISAF) yesterday shows three boxes of the contrast agent imported from Spain.
