FDAMarch 4, 2025drug
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
What to do
FDA enforcement status: Ongoing
Brands named
chattem
UPCs
04116700140
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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