Duloxetine Delayed-Release Capsules USP 30 mg recall: Impurity Out of Spec
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Why was Duloxetine Delayed-Release Capsules USP 30 mg recalled?
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, exp. date Jan-25
- Product
- Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
- Recalling firm
- Rising Pharma Holding, Inc.
- Quantity
- 42,527 bottles
- Distribution
- Nationwide
- Recall date
- January 15, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)