Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.

FDA recall notice · announced June 19, 2019 · Chiesi

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lots: 3171856, Exp. 12/19
Quantity: 2598 bottles
Status: Terminated
Products in this recall event:
- ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12. (D-1341-2019)
- Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32. (D-1342-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.