Duloxetine Delayed-Release Capsules recall: Impurity Out of Spec
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by…
Why was Duloxetine Delayed-Release Capsules 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?
220265: Exp. Feb 2025 220088: Exp. Nov 2024 220267: Exp. Feb 2025 220256: Exp. Feb 2025 220225: Exp. Jan 2025 220269: Exp. Feb 2025
- Product
- Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by…
- Recalling firm
- Breckenridge Pharmaceutical, Inc
- Quantity
- 281,554/90 & 1000 count bottles
- Distribution
- US Nationwide.
- Recall date
- May 15, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)