Drug 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.
D-0504-2017
Product summary
- Event
- Event 76443
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10,656 units total for both products
- Official record key
drug-enforcement:D-0504-2017
Official wording
Reason: Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Code information: Lot #: 098840, 098779, Exp.06/18.
Distribution pattern: Nationwide within United States
Derived failure modes
-
Potency or specification failure
out of specification