Chattem recalls
FDA enforcement reports naming Chattem Inc as the recalling firm.
- Recall reports
- 2
- Class I (serious)
- 0
- Most recent report
- Apr 23, 2025
- Apr 23, 2025Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles…Drug · Chattem IncCGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake LimitClass II
- Mar 19, 2025Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blis…Drug · Chattem IncCGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.Class II