Class II
Ongoing
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
- Company
- Chattem Inc
- Recall Initiated
- March 26, 2025
- Posted
- April 23, 2025
- Recall Number
- D-0362-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 129,240 bottles
- Firm Location
- Chattanooga, TN, United States
Reason for Recall
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
Distribution
Nationwide.
Lot / Code Info
LOT 22L603, EXP: Oct 2025; LOT 378999, EXP: Feb 2027
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