"Sertraline Sandoz" and "Lamotrigine Sandoz".
Recall
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Medicines
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16/12/2016
In a letter dated December 13, 2016, the marketing authorization holder informed its customers that the above-mentioned batches of "Sertraline Sandoz" and "Lamotrigine Sandoz" are being recalled. During the routine incoming goods inspection on the part of the manufacturer, it was determined that a mix-up of an excipient had occurred. Instead of carboxymethyl starch, the excipient carboxymethyl cellulose was used in the above-mentioned medicinal specialties.
| Name of the medicinal product | Sertralin Sandoz (50 und 100 mg) Lamotrigin Sandoz (25, 50, 100 und 200 mg) |
|---|---|
| Marketing authorisation number(s) | Sertralin Sandoz 50 mg – Filmtabletten: ZNr: 1-26440 Sertralin Sandoz 100 mg – Filmtabletten: ZNr: 1-26441 Lamotrigin Sandoz 25 mg - lösliche Tabletten: ZNr: 1-26075 Lamotrigin Sandoz 50 mg - lösliche Tabletten: ZNr: 1-26076 Lamotrigin Sandoz 100 mg - lösliche Tabletten: ZNr: 1-26077 Lamotrigin Sandoz 200 mg - lösliche Tabletten: ZNr: 1-26078 |
| Marketing authorisation holder | Sandoz GmbH |
| Batch number(s) | Sertralin Sandoz 50 mg - Filmtabletten: FL9727, FR5681, FV9149, GA2444, GJ6293, FJ3892, FV7164,FY1520, GA2441, GJ6294 Sertralin Sandoz 100 mg – Filmtabletten: FW7671, FM4171, FM4172, FR5714, FW9903, FW9904, GA5653, GF3132, GM2646 Lamotrigin Sandoz 25 mg - lösliche Tabletten: FL6206, FV7168, FY8834, GE6143 Lamotrigin Sandoz 50 mg - lösliche Tabletten: FS3514, FX2701, GH6702 Lamotrigin Sandoz 100 mg - lösliche Tabletten: FP4071, FT5582, GA0738, GE8806, GK4619 Lamotrigin Sandoz 200 mg - lösliche Tabletten: FK2833, FZ0295, FZ0297, GK0857 |
| Classification of the recall | II |
| BASG reference number | INS-640.001-1920 |
Further inquiry note
Page last modified:
12/07/2022