D-0504-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2017
- Initiation Date
- February 13, 2017
- Termination Date
- September 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,656 units total for both products
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.
Distribution Pattern
Nationwide within United States
Code Information
Lot #: 098840, 098779, Exp.06/18.