Drug Enforcement D-0567-2025

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Status

Ongoing

Classification

Class II

Report Date

August 13, 2025

Termination Date

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Product Information

Product description
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
Product quantity
16 bottles
Reason for recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Direct Rx
Address
94 Worldwide Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0567-2025
Event ID
97251
Recall initiation date
March 7, 2025
Center classification date
August 4, 2025
Code info
Lot #: 02AU2406, Exp 01/31/2027
More code info
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