Olanzapine melting tablets
Recall
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Medicines
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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 recall | 2 |
| BASG reference number | INS - 640.001 - 1279 |
Further inquiry note
Page last modified:
12/07/2022