Chiesi USA, Inc. recalls Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 4…
- Recall date
- May 31, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1342-2019
- FDA classification
- Class II
- Brand / firm
- Chiesi USA, Inc.
- Sold / distributed
- Nationwide in the USA.
Why it was recalled
Failed Dissolution Specifications: Out of specification result for dissolution.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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.
Get recall alerts
Free email alert whenever Chiesi USA, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Chiesi USA, Inc.