FDAFDA · Food and drugs·Recall number D-1150-2022
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
Published June 22, 2022 · Recall initiated: June 10, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.
- Lot
- Lots: M100070, M100239, Exp. 06/22, M100312, Exp.09/22, M100366, Exp.10/22
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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