Information about the recovery of the supply chain with a batch of Engerix B for children 10 micrograms/0.5 ml suspension for injection, hepatitis B vaccine (rDNA), adsorbed (HBV)
18.06.2014
Following to the Notice about the temporary interruption of distribution and use of the batch of Engerix B for children 10 microgram/0,5 ml suspension for injection, hepatitis B vaccine (rDNA), adsorbed (HBV), published on the 3rd June 2014, the Agency for Medicinal Products and Medical Devices (HALMED) is informing hereby about the recovery of the supply chain with the batch AHBVC 262 CD of this medicine.
The procedure of temporary interruption of distribution and use of this medicine was initiated on the caution assumption, due to a suspected quality defect report from a health professional.
Based on the investigation and special quality control of the medicine, it was concluded that the tested product samples were in compliance with the specification parameters. With regard to the testing results, the temporary interruption of distribution and use of the batch AHBVC 262 CD of this medicine is being lifted and the existing stocks may be dispensed and used again.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
