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