Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 10
Summary
The FDA issued a Class II for Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), by Rising Pharma Holding, Inc.. Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Details
Source
Drug Recall
External ID
D-0106-2025
Action Date
2024-12-11
Status
Ongoing
Category
drug
Product Description
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
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
Quantity Affected: 122,925 bottles
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Distribution
Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-19
Company
East Brunswick, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 64 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Rising Pharma Holding, Inc. has 12 FDA actions in our database, including 12 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Rising Pharma Holding, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Rising Pharma Holding, Inc. have FDA actions?
Rising Pharma Holding, Inc. has 12 FDA actions in our database, including 12 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0106-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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