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WHITEHALL PRIMATENE TABLETS, DRISTAN SPRAY LABELING PROBLEMS

This article was originally published in The Tan Sheet

Executive Summary

WHITEHALL PRIMATENE TABLETS, DRISTAN SPRAY LABELING PROBLEMS are cited in a Feb. 25 FDA warning letter that follows up on a Jan. 20-Feb. 1 inspection of Whitehall-Robins Labs' Madison, N.J. manufacturing facility. The warning letter notes that lots of Primatene Tablets were distributed between February and December 1993 with labeling "which failed to include the required pregnancy warning statement." Lots of Dristan 12-Hour Nasal Decongestant Spray were distributed between April and September 1993 with labeling "which failed to include the heart ailment/disease warning," the letter states.
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