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 recall3
BASG reference number INS - 640.001 - 1018
Email

Further inquiry note