Chattem Inc: Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60
Recall reason: CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit. Recalled by Chattem Inc. Distribution: Nationwide.. Classification (Class II — potential health risk). Affected lots/NDC/dates: LOT 22L603, EXP: Oct 2025; LOT 378999, EXP: Feb 2027. Return the recalled medication to the pharmacy where you purchased it for a full refund of the purchase price.
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