The Recall Desk

FDA (Drugs) recall action 77638

VistaPharm, Inc. recalled 2 products on 2017-08-09

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
2017-08-09
Critical
0
Units
16,095

Why these products were recalled

Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count 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

  • SevereFDA (Drugs)··2017-08-09

    VistaPharm Recalls Lactulose Solution Due to Microbial Contamination

    VistaPharm is recalling Lactulose Solution, USP, because the product failed microbial testing for yeast and mold counts.

    Product
    Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50
    Category
    Distribution
    7 states
  • ModerateFDA (Drugs)··2017-08-09

    VistaPharm Recalls Lactulose Solution Due to Microbial Contamination

    VistaPharm is recalling Lactulose Solution, USP, because the product failed microbial testing for yeast and mold counts.

    Product
    Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01
    Category
    Distribution
    7 states