Chiesi USA, Inc. recalls Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45
Recalled June 19, 2019 · FDA recall D-1342-2019 · Chiesi USA
Hazard
Failed Dissolution Specifications: Out of specification result for dissolution. · FDA Class II
Units
2598 bottles
Sold at
Nationwide in the USA.
Description
Failed Dissolution Specifications: Out of specification result for dissolution.
Product
Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
Manufacturer(s)
Chiesi USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →