D-0266-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- March 19, 2025
- Initiation Date
- March 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 180,696 cartons
Product Description
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0
Reason for Recall
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot# 252807, Exp: 5/31/2025; 252808, Exp: 6/30/2025; 372560, Exp: 11/30/2025; 489576, 493447, Exp: 4/30/2026.