FDA recall D-913-2013

VistaPharm, Inc. · Class II · drug

Product

Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771

Reason for recall

Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2013-07-04
Report date: 2013-08-28
Termination date: 2014-08-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-913-2013