FDARecalled Aug 13, 2025 · #D-0567-2025
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
Hazard
Class II — temporary health risk
Be the first to hear about future recalls.
Add the things you own to a watchlist. We’ll alert you the moment one matches.
Get started, freeDescription
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. Classification: Class II Distribution: Nationwide
Product details
- 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
- Type
- Drugs
- Manufacturer
- Direct Rx
- Model numbers
- 02AU2406
- UPCs
- —