Zileuton Extended-Release Tablets recall: Failed Dissolution
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin…
Why was Zileuton Extended-Release Tablets recalled?
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during 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: M100070, M100239, Exp. 06/22, M100312, Exp.09/22, M100366, Exp.10/22
- Product
- Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin…
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 3,216 bottles
- Distribution
- Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
- Recall date
- June 22, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)