FDA recall D-0362-2025

Chattem Inc · Class II · 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

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.

Key facts

Status: Ongoing
Initiation date: 2025-03-26
Report date: 2025-04-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Chattanooga, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0362-2025