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Executive Summary

MCNEIL TYLENOL CHILDREN'S ELIXIR RECALL IS A CLASS II action under FDA's system of classifying potential hazard indicating that the "possibility of serious consequence is remote." In a July 10 "Weekly Enforcement Report," FDA announced that the firm recalled 7 batches of the liquid Tylenol product in 4 and 16 ounce bottles. Earlier, McNeil had discovered traces of mold and yeast growing in samples examined during routine quality control testing procedures. According to the Johnson & Johnson subsidiary, the problem began when the product was reformulated to go alcohol-free. All contaminated batches were manufactured before March 1985, and the product has been reformulated since then, a McNeil spokesman indicated. In a July 18 press release, the company said that it had told whslrs. nationwide to return batches of the product. McNeil maintained that none of the contaminated batches had reached retailers' shelves. According to the FDA, the order requires distributors to return the recalled lots of the product, wherever it is. FDA indicated the 370,386 of the 4 ounce bottles were distributed in batch numbers SSF 228, SSF 229, SSF 233, SL4321, SP4462 and SL4309, and 6,701 bottles were distributed in lot number SH3865. The Tylenol Children's Elixir recall generated considerable lay media attention during the week of July 18-19. Stories of the recall appeared in major national media on July 18-19.

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