Why it was recalled
Failed Dissolution Specifications: Out of specification result for dissolution.
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.
Lot numbers, UPCs & expiration codes
Lots: 3171856, Exp. 12/19
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1342-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 31, 2019
- FDA report date
- Jun 19, 2019
- Quantity
- 2598 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Chiesi USA, Inc.
Original FDA data
Every field from FDA enforcement report D-1342-2019, exactly as published.
Show all FDA fields
- City
- Cary
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 82993
- Address
- 175 Regency Woods Place, Ste. 600
- Code information
- Lots: 3171856, Exp. 12/19
- Postal code
- 27518-8128
- Report date
- Jun 19, 2019
- Product type
- Drugs
- Recall number
- D-1342-2019
- Classification
- Class II
- Recalling firm
- Chiesi USA, Inc.
- Product quantity
- 2598 bottles
- Termination date
- Mar 8, 2021
- Reason for recall
- Failed Dissolution Specifications: Out of specification result for dissolution.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- May 31, 2019
- Initial firm notification
- Letter
- Center classification date
- Jun 13, 2019