Reported Oct 14, 2020 · Terminated

NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL)…

VistaPharm, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: VistaPharm, Inc. · 7265 Ulmerton Rd · Largo, FL · 33771-4809

Is this the product you have?

    • NYSTATIN ORAL SUSPENSION
    • USP 100
    • 000
  • units per mL ContainsAlcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480
  • mL) Manufactured by
    • VistaPharm
    • Inc. Largo FL 33771
    • USA NDC 66689-008-16 UPC 6668900816
Lot codes and dates
  • Lots638800 Exp 10/21
Amount recalled
14,244 16 oz bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 28, 2022 · Data as of Sep 19, 6:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.