Why it was recalled
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
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
Lot numbers, UPCs & expiration codes
Lots: M100070, M100239, Exp. 06/22, M100312, Exp.09/22, M100366, Exp.10/22
Where it was sold
Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1150-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 10, 2022
- FDA report date
- Jun 22, 2022
- Quantity
- 3,216 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1150-2022, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 90415
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lots: M100070, M100239, Exp. 06/22, M100312, Exp.09/22, M100366, Exp.10/22
- Postal code
- 21202-6174
- Report date
- Jun 22, 2022
- Product type
- Drugs
- Recall number
- D-1150-2022
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 3,216 bottles
- Termination date
- Feb 8, 2023
- Reason for recall
- Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
- Recall initiation date
- Jun 10, 2022
- Initial firm notification
- Letter
- Center classification date
- Jun 15, 2022