Continued information about the recall of the batch 2A74306 of the medicinal product Perfalgan 10 mg/ml solution for infusion
29.03.2013
The company PharmaSwiss d.o.o., the marketing authorisation holder for the medicinal product Perfalgan 10 mg/ml solution for infusion, upon request of the Agency for Medicinal Products and Medical Devices is recalling the batch 2A74306 of the medicinal product Perfalgan 10 mg/ml solution for infusion, due to a discovered quality defect.
The decision about the recall is based on the test results obtained by HALMED of the batch 2A74306, according to the announcement posted on 9 January, 2013.
All stocks of the batch 2A74306 of the medicinal product Perfalgan 10 mg/ml solution for infusion were, from 9 January 2013, according to the announcement on HALMED’s webpages, marked and recalled from stocks of hospital pharmacies and a ban on dispension of the batch to patients was in effect.
There are sufficient batches of the medicinal product Perfalgan 10 mg/ml on stock in Croatia, that are not affected by the suspected quality defect and recall from the market.
Here you may view the Dear Health care Professiona letter (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.
