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Antifungal Med Recalled


February 21, 2017

VistaPharm, Inc is pulling 67,955 bottles of Nystatin Oral Suspension, USP 100,000 units per mL, from the US market because of potential contaminations during manufacturing (http://bit.ly/2liHa9h).

“CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia,” was listed in a US Food and Drug Administration (FDA) Enforcement Report as the official reason for the ongoing, Class II recall.

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The antifungal medication is packaged in 24-bottle cases (2 fl oz [NDC 66689-008-02]) and 12-bottle cases (16 fl oz [NDC 66689-008-16]). Affected products include lot numbers:

  • 422600 (Exp. 10/17), 420000 (Exp. 09/17), 416100 (Exp. 08/17), 417400 (Exp. 09/17)
  • 424200 (Exp. 10/17), 415500 (Exp. 03/18)

VistaPharm voluntarily initiated the recall last month on January 18, 2017 and the impacted drugs were distributed throughout the United States.

The FDA describes a Class II recall as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”—Sean McGuire

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