Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
Reported: October 23, 2024 Initiated: October 10, 2024 #D-0009-2025
Product Description
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Details
- Recalling Firm
- Breckenridge Pharmaceutical, Inc
- Units Affected
- 7,107 bottles
- Distribution
- Product was distributed nationwide within the United States
- Location
- Berlin, CT
Frequently Asked Questions
What product was recalled? ▼
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.. Recalled by Breckenridge Pharmaceutical, Inc. Units affected: 7,107 bottles.
Why was this product recalled? ▼
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 23, 2024. Severity: Moderate. Recall number: D-0009-2025.
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