Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
Reported: June 19, 2019 Initiated: May 31, 2019 #D-1342-2019
Product Description
Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
Reason for Recall
Failed Dissolution Specifications: Out of specification result for dissolution.
Details
- Recalling Firm
- Chiesi USA, Inc.
- Units Affected
- 2598 bottles
- Distribution
- Nationwide in the USA.
- Location
- Cary, NC
Frequently Asked Questions
What product was recalled? ▼
Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.. Recalled by Chiesi USA, Inc.. Units affected: 2598 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Out of specification result for dissolution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 19, 2019. Severity: Moderate. Recall number: D-1342-2019.
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