Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 5 Supply Disruption — Breckenridge Pharmaceutical,
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 5 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, 30mg, Rx Only, 90-count bottles (NDC 5; Manufacturer: Brecke
| Drug name | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 5 |
|---|---|
| Manufacturer | Breckenridge Pharmaceutical, Inc |
| Recall/Disruption reason | CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Ongoing |
| Record type | Enforcement/Recall |
| Recall number | D-0161-2025 |
| Initiation date | 20241206 |
| Quantity affected | 163,883 bottles |
| Dosage form | Drugs |
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