Olanzapine melting tablets
Recall
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Medicines
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30/06/2015
In a letter dated June 26, 2015, the marketing authorization holder informed its customers that ongoing stability tests have revealed values outside the specification for the degradation product ketolactam. The reason lies in a too long holding time of the bulk product and concerns two batches in Austria, which will probably not comply with the specification for the known impurity ketolactam until the end of the 36-month period.
| Name of the medicinal product | 1. Olanzapin Sandoz 10 mg – Schmelztabletten 2. Olanzapin Sandoz 15 mg – Schmelztabletten |
|---|---|
| Marketing authorisation number(s) | 1. 1-30621 2. 1-30622 |
| Marketing authorisation holder | Sandoz GmbH |
| Batch number(s) | 1. CZ2924 2. EL3439 |
| Classification of the recall | 2 |
| BASG reference number | INS - 640.001 - 1437 |
Further inquiry note
Page last modified:
12/07/2022