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
Reported: March 26, 2025 Initiated: March 5, 2025 #D-0277-2025
Product Description
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
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Details
- Recalling Firm
- Rising Pharma Holding, Inc.
- Units Affected
- 1223 bottles
- Distribution
- Nationwide in the USA.
- Location
- East Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Rising Pharma Holding, Inc.. Units affected: 1223 bottles.
Why was this product recalled? ▼
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 26, 2025. Severity: Moderate. Recall number: D-0277-2025.
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