Duloxetine Delayed-Release Capsules USP recall: Impurity Out of Spec
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For…
Why was Duloxetine Delayed-Release Capsules USP recalled?
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the 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?
Lot DT6023061B Exp 01/31/2025
- Product
- Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For…
- Recalling firm
- Amerisource Health Services LLC
- Quantity
- 20,734 30-count bottles
- Distribution
- Nationwide in the USA
- Recall date
- January 1, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)