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Executive Summary

LILLY FASPAK RECALL ENCOMPASSES UP TO 7,218 CASES OF ANTIBIOTICS due to imperfect packaging seals that "could allow moisture to get to the product and cause product potency to fall below USP lower standards," according to FDA's Nov. 15 (ITALICS)Enforcement Report. Products subject to the Class II recall [see full list below] include ampicillin sodium, Keflin (cephalothin sodium), Kefurox (cefuroxime sodium), Kefzol (cefazolin), Mandol (cefamandole nafate), and Tazidime (ceftazidime). Lilly initiated the recall Sept. 29 with a letter and visits to its customers. At that time, the firm said that a three-to-six week supply of each of the antibiotics was in distribution. Based on the three-to-six week supply, the company estimated that 3,429 to 7,218 cases remained on the market. The last week of October, one month after the recall was initiated, hospital pharmacists were reporting shortages with at least two of the products -- Kefzol and Tazidime ("The Pink Sheet" Nov. 6, p. 3). The firm notified wholesalers at that time that certain products were in limited supply and that it would be making many products available to hospitals through drop-shipments. * The Faspak recall coincides with a series of Lilly production and supply difficulties. The firm suspended shipment of all tablet products from its Building 100 Indianapolis facility in late August after FDA issued an adverse inspection report on the facility. That inspection resulted in the recall of 10 products that did not meet NDA manufacturing specifications ("The Pink Sheet" Sept. 18, p. 6), and was followed by the Oct. 27 recall of eight lots of Axid because of potential stability problems. The company began reshipping the first products from Building 100 at the beginning of November. In a recent presentation to analysts, Lilly acknowledged the manufacturing control problems but emphasized that "quality" is part of the company's corporate philosophy. Lilly Chief Financial Officer James Cornelius told the Nov. 21 Mabon Nugent seminar: "This corporate vision that's driving some of our activities . . . has us targeting highly innovative products, it has us becoming a world leader in life sciences, . . . and hopefully the word 'quality' -- you may have some questions about that given our recent 483s [FDA inspection observation reports] -- but that still continues in the charter."

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