Drug Enforcement D-0362-2025

CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit

Status

Ongoing

Classification

Class II

Report Date

April 23, 2025

Termination Date

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Product Information

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
Product quantity
129,240 bottles
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
Recall initiation reason
—
Initial firm notification
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Distribution pattern
Nationwide.

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-0362-2025
Event ID
96552
Recall initiation date
March 26, 2025
Center classification date
April 11, 2025
Code info
LOT 22L603, EXP: Oct 2025; LOT 378999, EXP: Feb 2027
More code info
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