Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Phar...
FDA Recall #D-1150-2022 — Class II — June 10, 2022
Product Description
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 for Recall
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Recalling Firm
Lupin Pharmaceuticals Inc. — Baltimore, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3,216 bottles
Distribution
Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
Code Information
Lots: M100070, M100239, Exp. 06/22, M100312, Exp.09/22, M100366, Exp.10/22
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated