FDAFDA · Food and drugs·Recall number D-1342-2019
Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
Published June 19, 2019 · Recall initiated: May 31, 2019
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 result for dissolution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Chiesi USA, Inc.
- Distributor
- Nationwide in the USA.
- Lot
- Lots: 3171856, Exp. 12/19
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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