Ibandronic acid

Recall | Medicines | 18/04/2013

The marketing authorization holder informed its customers in a letter dated April 18, 2013, that due to a technical defect during production, isolated particles were observed in the prefilled syringes. In the course of a 100% inspection, prefilled syringes with particles were sorted out. Nevertheless, both batches CV2391 and CU9980 are recalled as a precautionary measure.

Name of the medicinal product Ibandronsäure Sandoz 3 mg/3 ml - Injektionslösung
Marketing authorisation number(s) 1-30134
Marketing authorisation holder Sandoz GmbH, Kundl
Batch number(s) CV2391 und CU9980
Classification of the recall 2
BASG reference number INS-640.001-0725

Further inquiry note