FDARecalled Jan 1, 2025 · #D-0161-2025
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 Pharma...
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: Nationwide in the US
Product details
- 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.
- Type
- Drugs
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Model numbers
- 222205C
- UPCs
- —