Duloxetine Delayed-Release Cap USP 30mg recall: Impurity Out of Spec
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Why was Duloxetine Delayed-Release Cap USP 30mg recalled?
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA 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 #: J2022G, Exp: 01/01/2025
- Product
- Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Quantity
- 66 bottles of 30 tablets
- Distribution
- Product distributed to CA, FL, OK, KS and CT
- Recall date
- May 29, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)