Distribution, Manufacturing and Inspection

Notice on the recall of three batches of Medoclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)

14.10.2015

The Agency for Medicinal Products and Medical devices (HALMED) would like to inform on the recall of the batches B514AD and BL10AD of Medoclav 1000 mg + 200 mg powder for solution for injection or infusion of the marketing authorisation holder Medicuspharma d.o.o. from the Croatian market due to a suspected quality defect.

Further information is accessible under th elink bellow.

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Follow-up notice on preventive recall of three batches of medicinal product Betrion mast (mupirocin)

25.08.2015

Following the increased public interest on recall of three batches of medicinal product Betrion mast (mupirocin), which HALMED reported about on 19 August 2015, we would like to inform the following:

Recall of batches No. 331104, 332104, 131084 of the medicinal product Betrion mast carried out by Pliva Croatia d.o.o., the marketing authorisation holder, has been conducted preventively to the wholesale level.

The recall was carried out due to suspicion that the active substance mupirocin, batch W656993, which was used in the production of batches listed above, might have been contaminated by penicillin during the manufacturing. However, examination of indicated batches of medicinal product did not show presence of any penicillin component. Therefore, the decision to recall the medicine to the level of wholesale has been made as a precautionary measure.

This suspected quality defect cannot cause serious health consequences for patients. Pharmacies may continue to issue the remaining supplies of these batches of medicinal product. Patients can continue to use batches listed above and there is no need for returning previously issued packagings of this medicinal product to pharmacies.

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Recall of three batches of the Betrion mast (mupirocin)

25.08.2015

Company Pliva Hrvatska d.o.o., the marketing authorisation holder of the Betrion mast (mupirocin), has notified Agency for Medicinal Products and Medical Devices (HALMED) about the recall of batches no. 331104, 332104, 131084 of this medicinal product, due to suspected quality defect.

The suspicion in quality defect is based on potential penicillin contamination of active substance batch no. W656993 which has been used in production of mentioned batches. The recall is carried out to the level of wholesales.

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Notice on temporary discontinuation in the supply chain and use of the batch 718356 of Augmentin 1000 mg+200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)

11.06.2015

GlaxoSmithKline d.o.o., the marketing authorisation holder for Augmentin 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid), has notified the Agency for Medicinal Products and Medical Devices (HALMED) of a temporary discontinuation in the supply chain and use of the batch 718356 of this medicinal product due to a suspected quality defect.

The suspicion in a quality defect is following to an inspection by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) at the GSK manufacturing site in Worthing, UK. This discontinuation of the supply chain and use will be in effect by the end of the GMP audit.

According to HALMED’s data, this batch is no longer available in wholesalers in the Republic of Croatia.

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Notice on temporary discontinuation of supply chain and use of batches 15HK11F2 and 15HL218F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion and batches 15IB15P2 of Ciprofloxacin Kabi 200 mg/100 ml solution for infusion.

26.05.2015

Fresenius Kabi d.o.o., the marketing authorisation holder for Ciprofloxacin Kabi 400 mg/200 ml solution for infusion, Fresenius Kabi d.o.o., has initiated upon request of the Agency for Medicinal Products and Medical Devices (HALMED) a procedure of temporary disruption of distribution and use of the batches: 15IB515P2 of Ciprofoxacin Kabi 400 mg/200 ml solution for infusion and batches 15IB15P2 of Ciprofoxacin Kabi 200 mg/100 ml solution for infusion in the Republic of Croatia.

The procedure of discontinuation of distribution and use of these batches has been initiated over concern on a suspected quality defect based on an increased number of suspected adverse reactions to these medicines reported to HALMED in the last several weeks.

More information is accessible under the link below.

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Notice on recall of the batch 14160 of Yondelis 0.25 mg powder for concentrate for solution for infusion (trabectedin)

10.04.2015

PharmaMar S.A., marketing authorisation holder for Yondelis 0.25 mg powder for concentrate for solution for infusion (trabectedin), has notified the Agency for medicinal Products and Medical Devices (HALMED) on the recall of the batch 14160 of this medicine due to a discovered quality defect. The quality defect consists of a risk of foreign particles in vials. As a precaution measure, further distribution and use of this batch is stopped in all hospital settings in the Republic of Croatia, where this medicine is used.The recall of this batch is being conducted at the hospital level.

Further information is accessible under the link below.

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Notice on recall of one batch of Oronazol 20 mg/g shampoo

23.03.2015

Johnson & Johnson S.E. d.o.o., the marketing authorisation holder for Oronazol 20 mg/g shampoo has notified the Agency for Medicinal Products and Medical Devices (HALMED) of the recall of the batch EKB1Z00, EUR code: 6160803 from wholesalers and pharmacies. The recall is being conducted due to a batch labelled in Slovenian and mistakenly placed on the Croatian market during distribution.

This recall of the medicine labelled for the Slovenian market will not affect the regular supply chain with this medicine in Croatia.

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Notice on returning of the batch of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion to the Croatian market

13.03.2015

Following to the Notice on temporary supply and use discontinuation of the batch 15HG229F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion, published on 14 November 2014, the Agency for Medicinal Products and Medical Devices (HALMED) hereby informs on the returning of the batch 15HG229F1 of this medicinal product.

The procedure of discontinuation of the supply chain and use of this medicine was initiated as a precautionary measure, due to a suspected quality defect following to an allergic adverse reaction reported to HALMED.
Based on the conducted investigation and special quality control, HALMED concludes that the samples of the medicine comply to the specification with regard tested parameters. Following to these results, the temporary discontinuation of the supply chain and use of the batch 15HG2291 of this medicine is being alleviated and the existing stocks may be returned to distribution and use.

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