Four lots of VistaPharm Inc.’s Nystatin Oral Suspension, an antibiotic used to treat fungal infections of the mouth including oral thrush, were found to be contaminated with the Burkholderia cepacia, a bacteria that can cause life threatening bloodstream infections, particularly in patients with weakened immune systems. B. cepacia infections can range from mild with no symptoms to severe with serious respiratory symptoms. It is especially dangerous to patients with cystic fibrosis.
VistaPharm identified the source of the bacterial contamination as likely being purified water that was used to manufacture the drug products. Affected products include prescription only Nystatin Oral Suspension, USP 100,000 units per mL, with the NDC 66689-008-02. Affected lot numbers and expiration dates include Lot No. 416100 (08/17), 420000, 417400 (09/17), 422600 (10/17).
The recall is pending until the Food and Drug Administration (FDA) classifies the recall as a Class I, II, or III action. Class I recalls are the most serious type and involve situations in which there is a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.
The FDA has started posting pending recalls through a pilot program aimed at expediting notifications of human drug product recalls to the public. Any adverse events related to use of this product should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.