FDA-Drug2019-06-19Class II
Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
Chiesi USA, Inc.
Hazard
Failed Dissolution Specifications: Out of specification result for dissolution.
Sold states
Nationwide in the USA.
Affected count
2598 bottles
Manufactured in
175 Regency Woods Place, Ste. 600, N/A, Cary, NC, United States
Products
Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1342-2019Don't want to check this manually?
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