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Class II Recall
Lupin Pharmaceuticals Inc.
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
Reason
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Classification
Class II
Status
Terminated
Lot
Lots: M100070, M100239, Exp. 06/22, M100312, Exp.09/22, M100366, Exp.10/22
Date
2022-06-22
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.