Duloxetine Delayed-release Capsules USP recall: Impurity Out of Spec
Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured…
Why was Duloxetine Delayed-release Capsules USP recalled?
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
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: 18103 Exp. 11/18
- Product
- Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured…
- Recalling firm
- AVKARE Inc.
- Quantity
- 274 cartons
- Distribution
- Nationwide in the USA
- Recall date
- November 8, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)