Copley Pharmaceutical

Boston U.S. Attorney's investigation of the generic drug company will not be limited to albuterol sulfate .5% solution and over-the-counter Brompheril (antihistamine/decongestant), firm reports Dec. 6. Copley recalled albuterol sulfate .5% solution in January because of line drainage problems. In September, the firm initiated a Class II recall of Brompheril over concerns that the coating process did not follow batch records. To address the production problems, Copley recruited former FDA Director of Biopharmaceutics Jerome Skelly, who joined as VP-scientific affairs in charge of the divisions of regulatory affairs, R&D and technical services ("The Pink Sheet" Nov. 14, T&G-6)