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Executive Summary

SANDOZ RECALLING 15,000 CLOZARIL TABLETS DUE TO PACKAGING ERROR involving the company's SandoPak 100 mg unit dose blister- packs. The Class I recall, which was initiated after a pharmacist alerted Sandoz to a problem with the blister-packs, covers four lots of the anti-psychotic. The firm notified pharmacists and wholesalers by mail late last week that because of an error during the packaging process, some of the blister cavities contained two 100 mg tablets of Clozaril instead of one. The manufacturing error apparently occurred after the company changed the vinyl film material used in the blister-packs, which led to uneven filing of the blister cavities. In the letter to pharmacists, Sandoz emphasizes that "patients taking Clozaril (clozapine) should only take the dosage that is prescribed by their physicians in an effort to avoid certain dose- related adverse reactions, such as seizure." The drug also has been associated with the potentially life-threatening side effect of agranulocytosis, a severe reduction in white blood cells. The firm asks pharmacists to visually inspect all Clozaril 100 unit blister-packs before dispensing them to patients. "In some cases where there are two tablets per blister cavity, the tablets may be crushed or cracked, or the bottom tablet may not be readily visible," the company said. Pharmacists are directed to return to Sandoz any blister-packs containing more than one tablet per cavity. On July 30, Sandoz signed a consent agreement with the Federal Trade Commission concerning the company's marketing tactics for Clozaril. The agreement prohibits the firm from "requiring any purchaser of clozapine, or a patient taking clozapine sold by Sandoz, to buy other goods or services from Sandoz or anyone designated by Sandoz." FTC charged Sandoz with illegally requiring purchasers of its schizophrenia drug to buy Sandoz-arranged distribution and patient monitoring services. The final consent agreement contains certain modifications to a June 1991 proposed agreement ("The Pink Sheet" June 24, 1991, T&G-11). Those modifications require Sandoz to provide adverse reaction data to other firms upon request, at a cost of $10 or less. In addition, Sandoz may not "unreasonably withhold" data on clozapine patients from scientists and researchers for a period of eight years and may not charge a fee for such information.

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