Notices on Recalls and Suspension of Distribution of Medicinal Products - Quality Defects and Recalls | Distribution, Manufacturing and Inspection .: HALMED

Notice on recall of Ramipril H Farmal 5 mg/25mg tablets (ramipril, hydrochlorothiazide)

02.03.2015

Farmal d.d., the marketing authorisation holder for Ramipril H Farmal 5 mg/25 mg tablets (ramipril, hydrochlorothiazide) has notified the Agency for Medicinal Products and Medical Devices (HALMED) on the recall of the batch 140802 of this medicine due to a discovered quality defect. The quality defect relates to the labelling on the aluminium foil on blisters in Ramipril H Farmal 5 mg/25 mg tablets, where there is an incorrect product name Ramipril Farmal 5 mg tablets (ramipril) instead of Ramipril H farmal 5mg/25 mg tablets (ramipril, hydrochlorothiazide).

It is a pharmacy level recall.

Further information is accessible under the link below.

Notice on temporary discontinuation in the supply chain and use of the batch BL10AD of Medioclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid)

02.03.2015

Medicuspharma d.o.o., the marketing authorisation holder for Medoclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid), in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) has initiated a procedure of temporary discontinuation in the supply chain and use of the batch BL10AD of Medoclav 1000 mg + 200 mg powder for solution for injection or infusion (amoxicillin, clavulanic acid).

The procedure of discontinuation in the supply chain and use of this batch is being conducted following to a reported quality defect by a healthcare professional. The quality defect relates to appearance of an unusual colour of the diluted product (dark yellow solution colour).

Further information is accessible under the link below.

Notice on re-marketing of the batch HC 68E of Campto 100 mg/5 ml concentrate for solution for infusion (irinotecan)

23.02.2015

Further to the Notice about temporary interruption of distribution and use of the batch HC 68E of Campto 100 mg/5 ml concentrate for solution for infusion (irinotecan), published on 18 July 2014, the Agency for Medicinal Products and Medical Devices (HALMED) hereby informs about re-marketing of the said batch.

The procedure of temporary interruption of distribution and use of the said batch was launched as a precautionary measure due to a suspected quality defect report on the discovered turbid solution received by healthcare professionals.

Since based on the investigation the quality defect has not been confirmed, the temporary interruption of distribution and use of the batch HC 68E of this medicine has been revoked, and the existing stock can be dispensed and used again.

More information is accessible under the link below.

Temporary suspension of placing on the market of nine medicinal products due to non-compliance with the good clinical practice

23.01.2015

Based on recommendations of the European Medicines Agency (EMA), the Agency for Medicinal Products and Medical Devices (HALMED) temporarily suspended the placing on the market of nine medicinal products in Croatia due to non-compliance with the good clinical practice. The clinical trials based on which the concerned medicinal products are authorised were carried out by GVK Biosciences at the investigational site in Hyderabad in India. Based on the fact that an inspection at the site discovered non-compliances with the good clinical practice rules, this temporary decision will be in effect until marketing authorisation holders have submitted new data, or carried out new trials on other sites.

In addition to the temporary suspension of placing on the market of these medicines, those medicines already on the market are being recalled to the pharmacy level.

This temporary suspension of placing on the market and recalls are being carried out as a precaution measures and are not initiated by safety reasons.

The list of medicines affected by the temporary suspension in Croatia is accessible here.