Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Reported: January 15, 2025 Initiated: December 30, 2024 #D-0190-2025
Product Description
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Reason for Recall
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Details
- Recalling Firm
- Rising Pharma Holding, Inc.
- Units Affected
- 244,460 bottles
- Distribution
- Nationwide
- Location
- East Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ. Recalled by Rising Pharma Holding, Inc.. Units affected: 244,460 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 January 15, 2025. Severity: Moderate. Recall number: D-0190-2025.
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