D-1150-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 22, 2022
- Initiation Date
- June 10, 2022
- Termination Date
- February 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,216 bottles
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.
Distribution Pattern
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