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.

FDA recall notice · announced March 8, 2017 · L. Perrigo

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide within United States
Lot/code information: Lot #: 098840, 098779, Exp.06/18.
Quantity: 10,656 units total for both products
Status: Terminated
Products in this recall event:
- 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. (D-0503-2017)
- 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. (D-0504-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.