NiQuitin Mini
Recall
|
Medicines
|
27/02/2014
In a letter dated February 21, 2014, the distributor informed the customers it supplied that marginal manufacturing deviations had been identified, which resulted in some NiQuitin Mini lozenges deviating in physical parameters (weight, diameter, height) from the internal manufacturer specifications. In any case, the approved finished product specifications have been met. The recall was therefore carried out at wholesale level as a precautionary measure, as the preparations meet their approved finished product specifications. There is no safety risk for these products.
| Name of the medicinal product | 1. NiQuitin Mini 1,5 mg Lutschtabletten 2. NiQuitin Mini 4 mg Lutschtabletten |
|---|---|
| Marketing authorisation number(s) | 1. 1-27982 2. 1-27983 |
| Marketing authorisation holder | GlaxoSmithKline Consumer Healthcare GmbH & Co.KG, Deutschland Vertrieb und Durchführung Rückruf: GlaxoSmithKline Pharma GmbH, Österreich |
| Batch number(s) | Alle beim Großhandel befindlichen Chargen |
| Classification of the recall | 3 |
| BASG reference number | INS - 640.001 - 1018 |
Further inquiry note
Page last modified:
12/07/2022