← DrugSupply
HomeDrug Supply Records

Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mf Supply Disruption — Breckenridge Pharmaceutical,

Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mf Supply Disruption — Breckenridge Pharmaceutical, is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mf; Manufacturer: Brecke

Drug nameDuloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mf
ManufacturerBreckenridge Pharmaceutical, Inc.
Recall/Disruption reasonCGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Risk classificationModerate Risk — Temporary Health Consequence
StatusOngoing
Record typeEnforcement/Recall
Recall numberD-0552-2025
Initiation date20250715
Quantity affected1,829 60-count bottles
Dosage formDrugs

🔍 Search all drug supply records →