Reported Jun 19, 2019 · Terminated
Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH…
Chiesi USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Chiesi USA, Inc. · 175 Regency Woods Place, Ste. 600 · Cary, NC · 27518-8128
Is this the product you have?
- Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only
- Distributed byPrasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32
- Lot codes and dates
- Lots
3171856Exp. 12/19
- Lots
- Amount recalled
- 2598 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Out of specification result for dissolution.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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