FDAMarch 7, 2025drug
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
What to do
FDA enforcement status: Ongoing
Brands named
direct rxdirect
UPCs
619190482306191904826061919048290
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDADULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.2026-06-22
- CPSCPressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards; Imported by Patoolio Direct2026-04-16
- CPSCFortemotus Direct Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails2026-02-12
- CPSCAgrish Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Sold on Amazon by Agrish Direct2026-01-08
- FDAwaterfront BISTRO brand Frozen Raw Shrimp EZ PEEL SHELL & TAIL ON Colossal 8-12 Count per Lb. Net wt. 32oz (2LB). Product is packaged in white flexible plastic pouch with multicolored labeling. UPC is 0 21130 13224 9. Product of Indonesia. DISTRIBUTED BY LUCERNE FOODS, INC. P.O. BOX 99 PLEASANTON...2025-12-18
- FDAMARKET 32 by Price Chopper brand, frozen RAW SHRIMP easy peel shell on 26/30 count per pound. Net 16oz. Product is packaged in a clear flexible plastic package with brown label and blue and green printing. UPC is 0 41735 01358 3. Product of Indonesia. PROUDLY DISTRIBUTED BY PRICE CHOPPER, INC. SC...2025-12-18
- CPSCDirect Scaffold Supply Recalls Casters for Baker Scaffolding Due to Fall Hazard2025-06-05
- FDAThe Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as veri...2025-05-01
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