Lupin Pharmaceuticals Inc. recalls Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Balt
Recalled June 22, 2022 · FDA recall D-1150-2022 · Lupin Pharmaceuticals
Hazard
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study. · FDA Class II
Units
3,216 bottles
Sold at
Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
Description
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Product
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
Manufacturer(s)
Lupin Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →