Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
Reported: December 11, 2024 Initiated: November 19, 2024 #D-0106-2025
Product Description
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma 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
- 122,925 bottles
- Distribution
- Nationwide.
- Location
- East Brunswick, NJ
Frequently Asked Questions
What product was recalled? ▼
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ. Recalled by Rising Pharma Holding, Inc.. Units affected: 122,925 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 December 11, 2024. Severity: Moderate. Recall number: D-0106-2025.
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