Class II
Ongoing
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
This recall is currently active, issued December 11, 2024. It was issued by Rising Pharma Holding, Inc..
- Company
- Rising Pharma Holding, Inc.
- Recall Initiated
- November 19, 2024
- Posted
- December 11, 2024
- Recall Number
- D-0106-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 122,925 bottles
- Firm Location
- East Brunswick, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Distribution
Nationwide.
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
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