FDA Drug Class III — Least Serious

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.

Hazard

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

Products

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.
Brand
L. Perrigo Company
UPC
Lot #: 098840, 098779, Exp.06/18.

Units Affected

10,656 units total for both products