FDA-Drug2013-08-28Class II

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

VistaPharm, Inc.
Hazard

Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.

Sold states
Nationwide.
Affected count
1,707,050 cups / 5ml ea.
Manufactured in
7265 Ulmerton Rd, N/A, Largo, FL, United States
Products
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-913-2013

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