FDAHealthNovember 19, 2024

Rising Pharma Holding, Inc. — Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

⚠️ 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: November 19, 2024

Nationwide.

What's affected?

Product: Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Brand: Rising Pharma Holding, Inc.
Lot code: DT2022023A

Additional details

a) Lot # DT2022023A, DT2022024A, DT2022025A, DT2022026A, DT2022027A, exp. date Nov-24 DT2023001B, DT2023004A, DT2023005A, DT2023006A, exp. date Jan-25

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 209,376 bottles.

View original FDA notice →

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