Zyflo CR extended-release tablets 600 mg Recall: Failed Dissolution
ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.
What is the FDA recall status?
The FDA record lists this recall as terminated. This does not establish that a retained recalled product is safe to consume or use. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions.
Why was Zyflo CR extended-release tablets 600 mg recalled?
Failed Dissolution Specifications: Out of specification result for dissolution.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.
Which lot codes, UPCs or models are affected?
Lots: 3171855, Exp. 12/19
- Agency record number
- D-1341-2019
- Product
- ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.
- Recalling firm
- Chiesi USA, Inc.
- Quantity
- 2118 bottles
- Distribution
- Nationwide in the USA.
- Recall started
- May 31, 2019
- Report date
- June 19, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)