Section 122P(vii) in The Drugs and Cosmetics Rules, 1945
(vii)The licensee shall on being informed by the licensing authority or the controlling authority that any part of any batch/unit of the substance has been found by the licensing authority or the Central License Approving Authority not to conform with the standards of strength, quality of purity specified in these rules and on being directed so to do, withdraw, from sales and so far as may in the particular circumstances of the case be practicable recall all issues already made from that batch/unit.
