Recalls / Class II
Class IID-0106-2025
Product
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
- Brand name
- Duloxetine
- Generic name
- Duloxetine Hydrochloride
- Active ingredient
- Duloxetine Hydrochloride
- Route
- Oral
- NDCs
- 57237-017, 57237-018, 57237-019
- FDA application
- ANDA090778
- Affected lot / code info
- a) 30s; DT3023019A, exp. date Jan-25 DT3023050A, exp. date Apr-25; b) 90s; DT3023022A, exp. date Jan-25; c) 1000s; DT3022108A, DT3022107A, DT3022106A, DT3022111A, DT3022109A, exp. date Nov-24, DT3023001A, DT3023003A, exp. date Dec-24, DT3023024A, DT3023020B, exp. date Jan-25 DT3023027A, DT3023028A, exp. date Feb-25, DT3023034A, exp. date Mar-25, DT3023049A, exp. date Apr-25, DT3023095A, exp. date Jul-25
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Recalling firm
- Firm
- Rising Pharma Holding, Inc.
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd Ste 1401, East Brunswick, New Jersey 08816-1149
Distribution
- Quantity
- 122,925 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2024-11-19
- FDA classified
- 2024-12-05
- Posted by FDA
- 2024-12-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0106-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.