Home / Recalls / Chattem Inc / D-0362-2025

D-0362-2025 Class II Ongoing

Recalled by Chattem Inc — Chattanooga, TN

Recall Details

Product Type: Drugs
Report Date: April 23, 2025
Initiation Date: March 26, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 129,240 bottles

Product Description

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

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 Pattern

Nationwide.

Code Information

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