Oncaspar solution for injection
Medicines
|
19/11/2013
The company responsible for distribution, sigma-tau ArzneimittelGmbH, 40212 Düsseldorf, Germany, informed its supplied customers on November 15, 2013, that individual containers of the above-mentioned batches may have fine cracks that may lead to leakage (presumed incidence: 1/5,000), which may pose a risk of microbial contamination. Replacements will likely be available in approximately two weeks. Until then, if an alternative treatment is not available, treatment with affected batches should only be carried out in individual cases under special precautions (see safety letter from sigma-tau).
| Name of the medicinal product | Oncaspar Injektionslösung Durchstechflasche mit 5ml Injektionslösung Pegaspargase (3750 I.E. L-Asparaginase) |
|---|---|
| Marketing authorisation number(s) | 30204.00.00 (Deutschland) |
| Marketing authorisation holder | sigma-tau Rare Diseases SA Rua dos Ferreiros, 260, 9000-082 Funchal, Portugal |
| Batch number(s) | ON3007D1, ON3007X2, ON3008D1, ON3008X2, ON3009X2, ON3010D1, ON3010X2 |
| Classification of the recall | 1 |
| BASG reference number | INS-640.001-0945 |
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Page last modified:
12/07/2022