Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by...
FDA Recall #D-0362-2025 — Class II — March 26, 2025
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
Recalling Firm
Chattem Inc — Chattanooga, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
129,240 bottles
Distribution
Nationwide.
Code Information
LOT 22L603, EXP: Oct 2025; LOT 378999, EXP: Feb 2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated