Duloxetine Delayed-Release Capsules recall: Nitrosamine Impurity
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by…
Why was Duloxetine Delayed-Release Capsules recalled?
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
What should I do if I have this product?
Review the official FDA enforcement record for current 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: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025
- Product
- Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by…
- Recalling firm
- Golden State Medical Supply Inc.
- Quantity
- 21,655 (30 count bottle), 34,149 (90 count bottle)
- Distribution
- Nationwide in the U.S.
- Recall date
- July 3, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)