Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771

FDA recall notice · announced August 28, 2013 · Vistapharm

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

The product

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.

Notes

Distribution: Nationwide.
Lot/code information: Lot # 240200, 243000, 244800, 245600, 250800 and 253600. Exp 06/13.
Quantity: 1,707,050 cups / 5ml ea.
Status: Terminated
Products in this recall event:
- Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771 (D-913-2013)

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