Recalls / Class III
Class IIID-0504-2017
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.
- Affected lot / code info
- Lot #: 098840, 098779, Exp.06/18.
Why it was recalled
Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Recalling firm
- Firm
- L. Perrigo Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, N/A, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 10,656 units total for both products
- Distribution pattern
- Nationwide within United States
Timeline
- Recall initiated
- 2017-02-13
- FDA classified
- 2017-03-01
- Posted by FDA
- 2017-03-08
- Terminated
- 2017-09-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0504-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.