FDAHealthDecember 2, 2024
RemedyRepack Inc. — 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 P
⚠️ CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 2, 2024
Nationwide in the US
What's affected?
- Product
- 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
- Brand
- RemedyRepack Inc.
- Lot code
- J0786744-061724
Additional details
a) NDC 70518-0937-04, Lot # J0786744-061724, Exp. 06/30/2025 b) NDC 70518-0937-03, Lot # B3002625-060524, Exp. 10/31/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: a) 1,564 cards, b) 799 bottles.
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