Drug recall
Duloxetine Delayed-Release Capsules, USP, 20 mg,, 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical…
FDA recall event 94483 · Class II · Breckenridge Pharmaceutical, Inc
Key facts
| Event ID | 94483 |
|---|---|
| Recall numbers | D-0482-2024, D-0483-2024, D-0484-2024 |
| Recalling firm | Breckenridge Pharmaceutical, Inc |
| Product type | Drugs |
| Products | Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc…, Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles…, Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit |
| Initiation date | Apr 29, 2024 |
| Report date | May 15, 2024 |
| City | Berlin |
| State | CT |
| Country | United States |
| FEI number | 3006362554 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: