D-0504-2017 Class III Terminated
FDA drug recall D-0504-2017 was initiated by L. Perrigo Company on Feb 13, 2017 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity. The recall status is terminated (terminated Sep 26, 2017). Affected quantity: 10,656 units total for both products.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 8, 2017
- Initiation Date
- Feb 13, 2017
- Termination Date
- Sep 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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0504-2017
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026