DRUG RECALLS DECLINED FOR 1998
This article was originally published in The Gold Sheet
Executive Summary
...by one-fourth from 1997 to the lowest level in over a decade in spite of an uptick in the number of OTC products called back from the market. The decline reflects a 50% drop in oral solid and injectable Rx recalls. Significant reductions occurred in labeling mix-ups, dissolution failures, and potency-related problems. Countering the overall downtrend for the year was a rise in recalls related to contamination, NDA/monograph non-compliance, and cGMP deficiencies. Consent decrees accompanied multi-product recalls for two drug producers and a biologics firm. [An eight-page tabulation of drug recalls listed in FDA "Enforcement Reports" during 1998 begins on page 9.]