FDA recall D-0652-2016

Product

Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157

Reason for recall

Labeling: label error on declared strength.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-01-18

Report date

2016-02-10

Termination date

2016-06-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allegan, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0652-2016