FDA-Drug2022-06-22Class II
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
Lupin Pharmaceuticals Inc.
Hazard
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Sold states
Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
Affected count
3,216 bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1150-2022Don't want to check this manually?
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