Why it was recalled
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Product description
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Lot numbers, UPCs & expiration codes
Lot # 240200, 243000, 244800, 245600, 250800 and 253600. Exp 06/13.
Where it was sold
Nationwide.
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-913-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 4, 2013
- FDA report date
- Aug 28, 2013
- Quantity
- 1,707,050 cups / 5ml ea.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm, Inc.
Original FDA data
Every field from FDA enforcement report D-913-2013, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 65756
- Address
- 7265 Ulmerton Rd
- Code information
- Lot # 240200, 243000, 244800, 245600, 250800 and 253600. Exp 06/13.
- Postal code
- 33771-4809
- Report date
- Aug 28, 2013
- Product type
- Drugs
- Recall number
- D-913-2013
- Classification
- Class II
- Recalling firm
- VistaPharm, Inc.
- Product quantity
- 1,707,050 cups / 5ml ea.
- Termination date
- Aug 4, 2014
- Reason for recall
- Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jul 4, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 21, 2013