FDAMarch 26, 2025drug
Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
What to do
FDA enforcement status: Ongoing
Brands named
chattem
UPCs
041167006702
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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