Recalls / Class II
Class IID-1150-2022
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
- Affected lot / code info
- Lots: M100070, M100239, Exp. 06/22, M100312, Exp.09/22, M100366, Exp.10/22
Why it was recalled
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 3,216 bottles
- Distribution pattern
- Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
Timeline
- Recall initiated
- 2022-06-10
- FDA classified
- 2022-06-15
- Posted by FDA
- 2022-06-22
- Terminated
- 2023-02-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1150-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.