Dear Healthcare Professional letter about the recall of the batch G0460-3 of the Typhim Vi vaccine
The company Medoka d.o.o., who is the marketing authorisation holder for the vaccine Typhim Vi solution for injection in a pre-filled syringe, vaccine against typhoid fever, polysaccharide, has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED), sent a letter to health care professionals about the recall of the batch G0460-3 based on a reported quality defect.
HALMED has received a report that a pre-filled syringe of the batch E0212-1 with the expiry date till 29 February 2012 was found in the packaging of the batch G0460-3. Therefore, due to precautions, it was decided to recall the entire G0460-3 batch from the Croatian market.
The marketing authorisation holder has informed about the recall all the health care facilities and pharmacies, where the aforementioned batch was delivered.
The text of the Dear Health Care Professional letter, you may view here (in Croatian).
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.