FDAClass IIIMarch 8, 2017

Salicylic Acid Cream recall: Impurity Out of Spec

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.

Why was Salicylic Acid Cream recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 098840, 098779, Exp.06/18.

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.
Recalling firm
L. Perrigo Company
Quantity
10,656 units total for both products
Distribution
Nationwide within United States
Recall date
March 8, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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