Drug product
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
D-0266-2025
Product summary
- Firm
- Chattem Inc
- Event
- Event 96391
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 180,696 cartons
- Official record key
drug-enforcement:D-0266-2025
Official wording
Reason: CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Code information: Lot# 252807, Exp: 5/31/2025; 252808, Exp: 6/30/2025; 372560, Exp: 11/30/2025; 489576, 493447, Exp: 4/30/2026.
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Foreign material or chemical contamination
Nitrosamine Drug Substance Related Issue impurity
-
Manufacturing or process control
CGMP Deviations