FDARecalled Mar 26, 2025 · #D-0277-2025
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Hazard
Class II — temporary health risk
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CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit. Classification: Class II Distribution: Nationwide in the USA.
Product details
- Product
- Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
- Type
- Drugs
- Manufacturer
- Rising Pharma Holding, Inc.
- Model numbers
- DTB23111A
- UPCs
- —