FDARecalled Oct 23, 2024 · #D-0009-2025
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.
Hazard
Class II — temporary health risk
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CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Classification: Class II Distribution: Product was distributed nationwide within the United States
Product details
- Product
- 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.
- Type
- Drugs
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Model numbers
- 220128
- UPCs
- —