Reported Jun 22, 2022 · Terminated
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc.,…
Lupin Pharmaceuticals 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: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174
Is this the product you have?
- Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
- Lot codes and dates
- Lots
M100070M100239Exp. 06/22M100312Exp.09/22M100366Exp.10/22
- Lots
- Amount recalled
- 3,216 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
This product could cause temporary or reversible health problems — stop using it.
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