SQUIBB, LEDERLE, WARNER CHILCOTT, GENEVA GENERICS

Executive Summary

SQUIBB, LEDERLE, WARNER CHILCOTT, GENEVA GENERICS (Ciba-Geigy) are among Bolar customers that have been affected by a recent round of Class II recalls involving 12 drug entities. The recalls were attributed by FDA to a lack of assurance that the products were "manufactured in conformity with conditions approved in the ANDAs." Although Bolar announced on Feb. 16 that it was recalling 13 additional drugs, FDA only just began to list the recalls in its "Enforcement Reports" (see listing below). Bolar initiated the recalls as a result of an ongoing audit of its applications and manufacturing processes ("The Pink Sheet" Feb. 19, p. 12). In September/October, Lederle suspended generic drug supply agreements with Bolar, Par, and four other companies caught up in the generic drug scandal ("The Pink Sheet" Nov. 6, T&G-15). Some of the Bolar products, however, were still in distribution channels at the time of the February recall.