Olanzapine melting tablets

Recall | Medicines | 05/12/2014

The marketing authorization holder informed its customers supplied with the product in a letter dated December 2, 2014, that all batches marketed had been reviewed because deviations had been identified in stability tests. For Austria, these tests identified a total of seven batches that could show an increase in the degradation products ketolactam and N-oxide at the end of the 36-month period. The cause is an excessively long holding time and the storage conditions of the bulk product. These seven affected batches are now being recalled as a precautionary measure, but a toxicological and medical risk assessment does not indicate any health risk due to possibly elevated levels of the impurities.

Name of the medicinal product 1. Olanzapin Sandoz 5 mg – Schmelztabletten
2. Olanzapin Sandoz 10 mg – Schmelztabletten
3. Olanzapin Sandoz 20 mg – Schmelztabletten
Marketing authorisation number(s) 1. 1-30620
2. 1-30621
3. 1-30623
Marketing authorisation holder Sandoz GmbH
Batch number(s) 1. CU7992, CZ2917, DH9219
2. CU7990, DH9280
3. CU6524, DC4008
Classification of the recall2
BASG reference number INS - 640.001 - 1279

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