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Chattem Inc FDA Recalls
2 recalls on file across drugs, 0 of them Class I and 2 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. BoClass IIMar 26, 2025CGMP Deviations; detection of Nitrosamine Drug Substance-Rel |
| Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavClass IIMar 4, 2025CGMP Deviations: Nitrosamine Drug Substance Related Issue im |