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FDA warns Sunrise on misbranded OTCs

This article was originally published in The Tan Sheet

Executive Summary

Sunrise Pharmaceutical Inc. makes non-monograph label claims for its diphenhydramine OTC products, rendering them unapproved new drugs, according to an FDA warning letter. The generic drug manufacturer claims its generic version of Johnson & Johnson's Benadryl is for temporary relief of hay fever and upper respiratory allergies - indications not in compliance with the antihistamine final monograph, according to the agency. The Jan. 14 warning letter also cites Rahway, N.J.-based Sunrise for a noncompliant Reye's syndrome warning on aspirin product labeling. FDA found multiple other violations relating to OTC labels and prescription drug good manufacturing practices during its inspection of Sunrise in June and July 2009
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