Key Takeaway

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. by L. Perrigo Company was recalled on February 13, 2017. The hazard: Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.

FDA Drug Class III Terminated

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.

Recalled: February 13, 2017 ~10,656 units total for both products units affected D-0503-2017

Description

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 / Reason

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

Class III: Product that is not likely to cause adverse health consequences.

Class III is the least severe classification. The product is unlikely to cause adverse health consequences but still violates FDA regulations.

Products Affected

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.

Drugs

Company Information

L. Perrigo Company

Allegan, MI, United States

View all 21 recalls by L. Perrigo Company →

Distribution

Nationwide within United States

Related Recalls

Frequently Asked Questions

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