Status
Ongoing
Drug Enforcement D-0266-2025
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Classification
Class II
Report Date
March 19, 2025
Termination Date
—
Product Information
- 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
- Product quantity
- 180,696 cartons
- Reason for recall
- CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
- Recall initiation reason
- —
- Initial firm notification
- —
- Distribution pattern
- Nationwide in the USA.
Location & Firm
- Recalling firm
- Chattem Inc
- Address
-
1715 W 38th St
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0266-2025
- Event ID
- 96391
- Recall initiation date
- March 4, 2025
- Center classification date
- March 10, 2025
- Code info
- Lot# 252807, Exp: 5/31/2025; 252808, Exp: 6/30/2025; 372560, Exp: 11/30/2025; 489576, 493447, Exp: 4/30/2026.
- More code info
- —