Paroxetine Extended-Release Tablets USP recall: Failed Dissolution
Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202…
Why was Paroxetine Extended-Release Tablets USP recalled?
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
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?
Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019
- Product
- Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202…
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 12480 bottles
- Distribution
- Nationwide in the USA
- Recall date
- July 19, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)