Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Supply Disruption — Breckenridge Pharmaceutical, I
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Supply Disruption — Breckenridge Pharmaceutical, I is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only,; Manufacturer: Brecke
| Drug name | Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, |
|---|---|
| Manufacturer | Breckenridge Pharmaceutical, Inc. |
| Recall/Disruption reason | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Ongoing |
| Record type | Enforcement/Recall |
| Recall number | D-0216-2026 |
| Initiation date | 20251124 |
| Quantity affected | 7389 bottles |
| Dosage form | Drugs |
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