FDAClass IISeptember 10, 2014

Comfort Shield Barrier Cream Cloths with dimethicone a) recall: Sterility Concern

Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three…

Why was Comfort Shield Barrier Cream Cloths with dimethicone a) recalled?

Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.

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: 44385; Exp.06/16; Lot: 44669; Exp.12/15

Product
Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SAGE PRODUCTS INC., 3909 Three…
Recalling firm
Sage Products Inc
Quantity
8-ct. 7,066 cases; 24-ct. 2,664 cases
Distribution
Nationwide
Recall date
September 10, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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