Recalls / Class II
Class IID-1342-2019
Product
Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
- Affected lot / code info
- Lots: 3171856, Exp. 12/19
Why it was recalled
Failed Dissolution Specifications: Out of specification result for dissolution.
Recalling firm
- Firm
- Chiesi USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 175 Regency Woods Place, Ste. 600, N/A, Cary, North Carolina 27518-8128
Distribution
- Quantity
- 2598 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2019-05-31
- FDA classified
- 2019-06-13
- Posted by FDA
- 2019-06-19
- Terminated
- 2021-03-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1342-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.