Class II
Terminated
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
This recall has been terminated (originally issued August 28, 2013).
- Company
- Vistapharm, Inc.
- Recall Initiated
- July 4, 2013
- Posted
- August 28, 2013
- Recall Number
- D-913-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,707,050 cups / 5ml ea.
- Firm Location
- Largo, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
Distribution
Nationwide.
Lot / Code Info
Lot # 240200, 243000, 244800, 245600, 250800 and 253600. Exp 06/13.
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