Drug 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

D-0362-2025

March 26, 2025

Class II

Product summary

Firm: Chattem Inc
Event: Event 96552
Status: Ongoing
Classification: Class II
Quantity: 129,240 bottles
Official record key: drug-enforcement:D-0362-2025

Official wording

Reason: CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit

Code information: LOT 22L603, EXP: Oct 2025; LOT 378999, EXP: Feb 2027

Distribution pattern: Nationwide.

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

Nitrosamine Drug Substance-Related Impurities
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations