FDA recall D-0504-2017

Product

Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruham, Israel 80500, Distributed By Perrigo Allegan, MI 49010, NDC 45802-806-01, UPC 3 45802-806-01 7.

Reason for recall

Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.

Distribution

Nationwide within United States

Key facts

Status

Terminated

Initiation date

2017-02-13

Report date

2017-03-08

Termination date

2017-09-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allegan, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0504-2017