Chattem Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
1
Inspections
11
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0362-2025Class IIUnisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by ChMarch 26, 2025
D-0266-2025Class IIUnisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs perMarch 4, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K131159SMARTRELIEFJuly 25, 2013