D-913-2013 Class II Terminated
FDA drug recall D-913-2013 was initiated by VistaPharm, Inc. on Jul 4, 2013 and is designated Class II. Reason for recall: Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months. The recall status is terminated (terminated Aug 4, 2014). Affected quantity: 1,707,050 cups / 5ml ea.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 28, 2013
- Initiation Date
- Jul 4, 2013
- Termination Date
- Aug 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,707,050 cups / 5ml ea.
Product Description
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Reason for Recall
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Distribution Pattern
Nationwide.
Code Information
Lot # 240200, 243000, 244800, 245600, 250800 and 253600. Exp 06/13.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-913-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026