Section 74(j) in The Drugs and Cosmetics Rules, 1945
(j)the licensee shall on being informed by the licensing authority [or the controlling authority] [Inserted by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).] that any part of any batch of the drug has been found by the licensing authority [or the controlling authority] [Inserted by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).] not to conform with the standards of strength, quality or purity specified in these rules and on being directed so to do, withdraw the remainder of the batch from sale, and, so far as may in the particular circumstances of the case be practicable, recall all issues already made from that batch;
