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

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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