Breckenridge Pharmaceutical, Inc Recall: Duloxetine Delayed-Release Capsules, USP, 30mg, R
Breckenridge Pharmaceutical, Inc Recall: Duloxetine Delayed-Release Capsules, USP, 30mg, R is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Breckenridge Pharmaceutical, Inc; Product: Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: To
| Recalling firm | Breckenridge Pharmaceutical, Inc |
|---|---|
| Product | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. |
| Reason for recall | CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Nationwide in the US |
| Recall initiated | 20241206 |
| Recall number | D-0161-2025 |
| Category | drug |
| State | CT |
| Country | United States |
$29/mo
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