Recalls / Class II

Class IID-0567-2025

Product

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

Affected lot / code info

Lot #: 02AU2406, Exp 01/31/2027

Why it was recalled

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

Recalling firm

Firm

Direct Rx

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

94 Worldwide Dr, N/A, Dawsonville, Georgia 30534-6828

Distribution

Quantity

16 bottles

Distribution pattern

Nationwide

Timeline

Recall initiated

2025-03-07

FDA classified

2025-08-04

Posted by FDA

2025-08-13

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0567-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.