Class II
Terminated
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
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- June 10, 2022
- Posted
- June 22, 2022
- Recall Number
- D-1150-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,216 bottles
- Firm Location
- Baltimore, MD, United States
Reason for Recall
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Distribution
Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
Lot / Code Info
Lots: M100070, M100239, Exp. 06/22, M100312, Exp.09/22, M100366, Exp.10/22
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