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

Reason: Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.

Code information: Lots: M100070, M100239, Exp. 06/22, M100312, Exp.09/22, M100366, Exp.10/22

Distribution pattern: Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.