The Pharmaceutical Supervision and Administration Bureau (ISAF) explained in a statement yesterday the findings of an investigation following the earlier recall of a nutritional supplement for pregnant women.
On August 6, the pharma bureau announced in a statement that it had received a report from local drug importers about a product imported from the United States that was found to have black spots on its softgels.
The problematic supplement titled “PRENATAL VITAMIN DHA SOFTGELS” produced by “Earth’s Creation USA” was found to have black spots on its softgels. As a precautionary measure, the drug importer has voluntarily recalled the affected batches of the product from the local market. The batch numbers are 22199 and 32149.
About the black spots on the softgels, according to the statement, the ISAF analysis indicates that the black spots were found to contain iron and vitamin C components derived from the capsule’s contents.
The statement said that the cause of the black spots has been determined as follows: iron and vitamin C from the contents migrated to the softgels’ shells, underwent a slow oxidation reaction that changed their colour, and subsequently combined with the inherent colour of the softgels’ shell to form the black spots. The phenomenon does not pose any risk to the product’s safety, the statement stressed.
According to the statement, the bureau has required the US manufacturer to improve the production process of the product concerned to prevent the recurrence of such issues.
This undated handout photo provided by the Pharmaceutical Supervision and Administration Bureau (ISAF) yesterday shows a bottle of the softgels affected by black spots, a prenatal supplement imported from the US.
