Myocholine-Glenwood Tablets
Recall
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Medicines
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15/12/2010
The distribution partner Croma-Pharma has informed the supplied customers by letter dated December 9, 2010, that the above mentioned batches have to be recalled due to reduced stability. The affected batches show a negative trend or Out of Specification results for the value of the impurity ß-methylcholine chloride in the ongoing stability studies.
| Name of the medicinal product | 1.Myocholine-Glenwood-Tabletten 10 mg 2.Myocholine-Glenwood-Tabletten 25 mg |
|---|---|
| Marketing authorisation number(s) | 1.17.338 2.17.339 |
| Marketing authorisation holder | Glenwood GmbH, D-82319 Starnberg Vertrieb in Österreich: Croma-Pharma Gesellschaft m.b.H |
| Batch number(s) | 1. 250108, 250209, 250309 2. 260108, 260208, 260308, 260408, 260608, 260109, 260309, 260409, 260509, 260609, 260709, 260809, 260110, 260210 |
| Classification of the recall | 2 |
| BASG reference number | 640.300/2010 |
Further inquiry note
Page last modified:
12/07/2022