Duloxetine Delayed-Release Capsules recall: Impurity Out of Spec
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured…
Why was Duloxetine Delayed-Release Capsules 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?
a) 30 count; Lot, expiry: DT3023019B, DT3023020A, exp 01/31/2025 b) 1000 count; Lot, expiry: DTB23098A, exp 08/31/2025
- Product
- Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured…
- Recalling firm
- Amerisource Health Services LLC
- Quantity
- 23,490 bottles
- Distribution
- PA, OH, PR
- Recall date
- December 11, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)