Distribution, Manufacturing and Inspection

Information about recall of the batch 0380313 of Docetaxel Pliva 20 mg concentrate and solvent for solution for infusion (docetaxel)

03.07.2014

Pliva Croatia d.o.o., the marketing authorisation for Docetaxel Pliva 20 mg concentrate and solvent for solution for infusion (docetaxel), has informed the Agency for Medicinal Products and Medical Devices (HALMED) abot the decision to recall the batch 0380313 of this medicinal product due to a quality defect. The quality defect was discovered during stability studies at 25°C/60%RH, after 12 months, where the obtained result was out of specification for the parameter Related substances.
There are sufficient quantities of Docetaxel Pliva 20 mg concentrate and solvent for solution for infusion batches not affected by this quality defect and recall and that are available on the Croatian market.
Detailed information is accessible under the link below.

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Notice on recall of one batch of Etoposide Pfizer 20 mg/ml concentrate for solution for infusion (etoposide) due to an error in the product name in the package leaflet and labelling

26.06.2014

Pfizer Croatia d.o.o., the marketing authorisation holder for Etoposide Pfizer 20 mg/ml concentrate for solution for infusion (etopodide), has informed the Agency for Medicinal Products and Medical Devices (HALMED) about the recall of the batch HW52C of this medicine. The recall is due to an error in the product name in the package leaflet and labelling.

Detailed information is accessible under the link below.

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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.
Detailed information is accessible under the link below.

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Information about counterfeited Kaletra (lopinavir, ritonavir) in Germany

17.06.2014

The Agency for Medicinal Products and Medical devices (HALMED) has received an information about a suspected counterfeit of Kaletra (lopinavir, ritonavir) in Germany. This medicine is used in treatment of human immunodeficiency (HIV-1) infection.
The suspected counterfeited medicine has been reported by a parallel trade company from Germany, who discovered during the check up of purchased quantities a non-conformity in labelling of the outer package and the package leaflet with the information figuring on the original product packaging.
The following batches are affected by the suspected counterfeit: 276268D, 345118D, 336398D. The manufacturer’s investigation is in the course and further distribution of these batches from the stock has been suspended.
Detailed information is accessible under the link below

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Information about printing error in the package leaflet of certain batches of Xeloda

16.06.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received a quality defect report for Xeloda (capecitabine). This is due to a printing error in the package leaflet of certain batches of Xeloda.
In the paragraph 1 of the package leaflet “What is Xeloda and what is it used for”, there is an incorrect statement that the medicine contains 150 mf of capecitabine instead of 500 mg capecitabine. The affected batches containing the correct amount of 500 mg of capecitabine per tablet, which ia clearly stated in other parts of the package leaflet and labelling. The following batches have been affected by this quality defect , which means a printing error: B3010B02, B3024B03, X3197B05, X3164B02, X3111B02, X3048B02 and B3038B04.
Detailed information is accessible under the link below.

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Information about the recall of Soliris 300 mg concentrate for solution for infusion

05.06.2014

The Agency for Medicinal Products and Medical Devices (HALMED) has received via rapid alert system from the Italian Medicines Agency the information that Alexion Europe SAS-France, the marketing authorisation holder for Soliris 300 mg concentrate for solution for infusion (eculizumab), has started a preventive recall procedure of certain batches of this medicinal product.
A recall procedure is being currently carried out from the healthcare settings in the Republic of Croatia where batches No 00017D, 00021C, 00023C,00024C and 12SOL2D, manufactured by using the Pall component, have been distributed.
Detailed information is available under the link below.

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Notice about 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)

03.06.2014

GlaxoSmithKline d.o.o., marketing authorisation holder for Engerix B for children 10 microgram/0.5 ml suspension for injection, hepatitis B vaccine (rDNA), adsorbed (HBV), has upon request of the Agency for Medicinal Products and Medical Devices (HALMED) carried out a procedure of temporary distribution and use interruption of the batch AHBVC 262CD of this medicine.
The procedure of temporary distribution and use interruption of this batch of the medicine has been initiated as a caution measure, due to a suspected quality defect reported from a healthcare professional. The suspected quality defect consists in the change in appearance of the medicine (less milky than usual) and presence of precipitate particles that do not dissolve by remaining at the room temperature.
Detailed information is accessible under the link below.

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Information about counterfeit Herceptin (trastuzumab) on the Czech market

26.05.2014

Following the previous information about the counterfeit Herceptin (trastuzumab) on the EU market, the Agency for Medicinal Products and Medical Devices (HALMED) has been informed about a suspected counterfeit Herceptin on the Czech market.
In the Czech Republic, a medicinal product was found to have different labelling of the expiry date and batch number on the inner and outer packaging and to be labelled in different languages. The inner package was labelled with the batch number H0758, whereas indicated batch number on the outer packaging was H4342B01. The inner packaging and the package leaflet were prepared in Romanian and Bulgarian, whereas the outer packaging was prepared in Romanian language.
Detailed information is accessible under the link below.

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Information on recall of falsified Norditropin SimpleXx 10 mg/1,5 ml solution for injection (somatropin) on the German market

23.05.2014

The Agency for Medicinal Products and medical Devices (HALMED) has received the information about a falsified Morditropim SimpleXx 10 mg/1,5 ml solution for injection (somatropin), used for growth failure and disorders on the German market. A falsified batch of the medicine has been discovered, batch No LL38548, shelf life 10/2015, that has never been released by the manufacturer, Novo Nordisk A/S, Denmark. This falsified medicine is suspected to be purchased in an illicit distribution chain in Germany.
Further information is accessible under the link below.

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