Duloxetine Delayed-Release Capsules USP recall: Impurity Out of Spec
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
Why was Duloxetine Delayed-Release Capsules USP 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 # DT2022023A, DT2022024A, DT2022025A, DT2022026A, DT2022027A, exp. date Nov-24 DT2023001B, DT2023004A, DT2023005A, DT2023006A, exp. date Jan-25
- 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
- Recalling firm
- Rising Pharma Holding, Inc.
- Quantity
- 209,376 bottles
- Distribution
- Nationwide.
- Recall date
- December 11, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)