Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
Reported: January 1, 2025 Initiated: December 2, 2024 #D-0165-2025
Product Description
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
Reason for Recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Details
- Recalling Firm
- RemedyRepack Inc.
- Units Affected
- a) 1,564 cards, b) 799 bottles
- Distribution
- Nationwide in the US
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA. Recalled by RemedyRepack Inc.. Units affected: a) 1,564 cards, b) 799 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 1, 2025. Severity: Moderate. Recall number: D-0165-2025.
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