Recalls / Class II
Class IID-0165-2025
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
- Affected lot / code info
- a) NDC 70518-0937-04, Lot # J0786744-061724, Exp. 06/30/2025 b) NDC 70518-0937-03, Lot # B3002625-060524, Exp. 10/31/2025
Why it was recalled
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- a) 1,564 cards, b) 799 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2024-12-02
- FDA classified
- 2024-12-26
- Posted by FDA
- 2025-01-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0165-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.