FDAHealthMarch 26, 2025
Chattem Inc — Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2
⚠️ CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 26, 2025
Nationwide.
What's affected?
- Product
- Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2
- Brand
- Chattem Inc
- Lot code
- 22L603
Additional details
LOT 22L603, EXP: Oct 2025; LOT 378999, EXP: Feb 2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 129,240 bottles.
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