Monday, Mar 13, 2000
South San Francisco, Calif. -- March 13, 2000 --Genentech, Inc. (NYSE: DNA) today announced that it is voluntarily issuing an important drug notification regarding a defect in the packaging of its cystic fibrosis drug, Pulmozyme® (dornase alfa, recombinant) Inhalation Solution. During a quality assurance inspection, the company discovered that a small puncture may be present in approximately one of every 1,700 ampules of Pulmozyme, potentially causing it to leak.
Genentech believes that the possible leaks are unlikely to cause adverse health effects since the product is refrigerated and given as a single dose. The company's product complaint and adverse event reporting systems have not revealed evidence of a change in the safety pattern of Pulmozyme as a result of the packaging defect.
Genentech is working with the United States Food and Drug Administration and is in the process of informing wholesalers, retailers and physicians. Genentech has implemented corrective actions to prevent recurrence of this defect, and the company does not foresee a disruption in the product supply.Wholesale and retail customers should continue providing existing product to physicians and patients. Genentech believes that the leaks in ampules are readily identifiable. Physicians are asked to inform their patients to examine their Pulmozyme for potentially defective ampules. Patients will be instructed to examine all Pulmozyme ampules from this point forward for leaks by squeezing ampules prior to use. Ampules with leaks should not be used and should be returned to Genentech according to instructions issued by the company. Questions regarding instructions and potentially defective ampules should be directed to Genentech Product Support at 1-800-334-0290. All unexpired ampules should be inspected prior to use. Genentech is advising physicians that ampules without leaks may continue to be used by patients. Expired ampules should not be used.
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