FDAHealthMarch 7, 2025
Direct Rx — 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
⚠️ CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 7, 2025
Nationwide
What's affected?
- 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
- Brand
- Direct Rx
- Lot code
- 02AU2406
Additional details
Lot #: 02AU2406, Exp 01/31/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 16 bottles.
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