Chattem Inc: Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime
Recall reason: CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.. Recalled by Chattem Inc. Distribution: Nationwide in the USA.. Classification (Class II — potential health risk). Affected lots/NDC/dates: Lot# 252807, Exp: 5/31/2025; 252808, Exp: 6/30/2025; 372560, Exp: 11/30/2025; 489576, 493447, Exp: 4/30/2026.. Return the recalled medication to the pharmacy where you purchased it for a full refund of the purchase price.
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