The Recall Desk

FDA (Drugs) recall action 85888

VistaPharm, Inc. recalled 2 products on 2020-07-15

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-07-15
Critical
0
Units
395,460

Why these products were recalled

Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • LowFDA (Drugs)··2020-07-15

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Exceeding Specifications

    VistaPharm is recalling Nystatin Oral Suspension because an impurity peak exceeded approved specifications. The affected product is distributed in the United States and Puerto Rico.

    Product
    Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··2020-07-15

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Peak

    VistaPharm is recalling Nystatin Oral Suspension cups because an impurity peak exceeded approved specifications. The recall covers 380,700 cups distributed in the United States and Puerto Rico.

    Product
    Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.
    Category
    Distribution
    1 state