FDARecalled Apr 9, 2025 · #D-0308-2025
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge...
Hazard
Class II — temporary health risk
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CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit. Classification: Class II Distribution: Nationwide in the US
Product details
- Product
- Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.
- Type
- Drugs
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Model numbers
- 240909C
- UPCs
- —