Executive Summary

SK&F RECALL OF 54,000 ANCEF VIALS STEMMED FROM FDA FINDINGS during a June inspection that the firm had found contamination during the later stages of sterility testing. According to the FDA inspection report, SmithKline explained that its procedures called for the release or rejection of the lyophilized cephalosporin based on a seven day testing period, and that the batches in question had been released when found sterile after seven days. However, according to FDA, the firm's records showed that followup monitoring of the batch samples had been done between seven and 14 days and that some contamination had been found during this follow-up period. SmithKline concluded that the positive test results reflected the testing procedures rather than contamination of the product itself. Testing of the returned samples has not revealed any contamination, the firm says. The company employs a membrane filtration sterility test on its cephalosporin samples. The seven-day regimen was adopted, the firm explained, in conformance with United States Pharmacopeial standards. According to USP, samples should be incubated "at 30 to 35 degrees for not less than seven days" when using the membrane filtration test. SmithKline said that following the inspection, it had decided to base its release criteria for the lyophilized cephalosporins on an extended 14 day testing period. The FDA report also critized SK&F for inadequately investigating positive results obtained during both its sterile product and environmental testing. The FDA investigators further pointed to evidence that SK&F personnel may have introduced contamination through their handling procedures during the sterile process, and cited the firm generally for a lack of "written procedures for evaluation of the training of filling room operators." SmithKline initiated the recall of the three Ancef batches on July 3 (the recall appeared in the July 23 FDA "Enforcement Report" as printed in the July 30 issue of "The Pink Sheet"). A followup request for response was sent out to hospitals on Aug. 22. According to the firm, about 50% of the hospitals receiving the recalled product have responded to date. The firm estimates that, as of the date of the recall, about 5% of the recalled product, distributed in late 1985 and 1986, remained on the market. Some 1,800 vials or 3% have now been returned. The recall involves only "a very small proportion" of the Ancef distributed over the last year, the firm said.