Flavamed - cough medicine withdrawn from the BiH market

(Patria)  Berlin-Chemie Menarini BH d.o.o., the marketing authorization holder for Flavamed 15 mg/5 ml oral solution, has informed the BiH Agency for Medicines and Medical Devices (ALMBiH) about the withdrawal of drug batches due to suspected quality defects.

Flavamed is used to treat coughs.

The suspected quality defect relates to a defect in the packaging, specifically the glass bottle for the solution, which leads to contamination. The withdrawal is being carried out down to the pharmacy level and applies to the batches of the mentioned drug affected by the suspected defect, as well as unaffected batches where the withdrawal is carried out as a precautionary measure.
 
The batches being withdrawn are 72011, 73030, 74045, 82011, 82012, 84025D, and 91001H.

One batch of the same drug that is not affected by this withdrawal is available on the BiH market, as well as other drugs used to treat the same condition that can be used as alternative therapy. Patients should consult their doctor or pharmacist if they have any questions regarding their current therapy.
 
"We remind healthcare professionals that they are obliged to report any adverse drug reactions or quality defects to ALMBiH. Patients who have developed any adverse reactions should consult their doctor or pharmacist for advice on how to continue their therapy," the Agency for Medicines announced.