SFDA found some case reports that individual children Appeared gluteal muscle contracture after intramuscular injection of injection containing Benzyl Alcohol through the monitoring the adverse drug reactions. To ensure the safety of children’s medication, SFDA decide to carry out the check the user manuals of Benzyl Alcohol Injection.
SFDA requires that if the prescription contains Benzyl Alcohol, the user manual must be clearly marked “this product contains Benzyl Alcohol, intramuscular injection to children prohibited”and if the products use Benzyl Alcohol as solvent, the user manual must be clearly marked “this product uses Benzyl Alcohol as solvent, intramuscular injection to children prohibited”.
The products are not allowed to be on the market if the user manuals have not been revised as such requirements. The products already in the market should be immediately recalled if the user manuals fail to state above content. |
