FDA recall D-0266-2025

Chattem Inc · Class II · 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

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

Nationwide in the USA.

Key facts

Status
Ongoing
Initiation date
2025-03-04
Report date
2025-03-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chattanooga, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0266-2025