1. Notwithstanding the measures provided for in Article 116, Member States shall take all appropriate measures to ensure that the supply of the medicinal product shall be prohibited and the medicinal product withdrawn from the market if:
(a) the medicinal product proves to be harmful under normal conditions of use, or
(b) it is lacking in therapeutic efficacy, or
(c) its qualitative and quantitative composition is not as declared, or
(d) the controls on the medicinal product and/or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out or if some other requirement or obligation relating to the grant of the manufacturing authorization has not been fulfilled.
2. The competent authority may limit the prohibition to supply the product, or its withdrawal from the market, to those batches which are the subject of dispute.