PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: March 8, 2017 Initiated: February 13, 2017 #D-0504-2017

Product Description

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.

Details

Recalling Firm
L. Perrigo Company
Units Affected
10,656 units total for both products
Distribution
Nationwide within United States
Location
Allegan, MI

Frequently Asked Questions

What product was recalled?
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.. Recalled by L. Perrigo Company. Units affected: 10,656 units total for both products.
Why was this product recalled?
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 8, 2017. Severity: Low. Recall number: D-0504-2017.