D-1150-2022 Class II Terminated
FDA drug recall D-1150-2022 was initiated by Lupin Pharmaceuticals Inc. on Jun 10, 2022 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study. The recall status is terminated (terminated Feb 8, 2023). Affected quantity: 3,216 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 22, 2022
- Initiation Date
- Jun 10, 2022
- Termination Date
- Feb 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1150-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026