FDA Drug Class III — Least Serious

Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham, Israel, Distributed By Perrigo Allegan, MI 49010, NDC 45802-237-01, UPC 3 45802-237-01 9.

Hazard

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

Products

Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham, Israel, Distributed By Perrigo Allegan, MI 49010, NDC 45802-237-01, UPC 3 45802-237-01 9.
Brand
L. Perrigo Company
UPC
Lot #: 099534, Exp. 07/18; 099512 Exp. 06/18.

Units Affected

10,656 units total for both products