Reported Sep 10, 2014 · Terminated

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.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sage Products Inc · 3909 3 Oaks Rd · Cary, IL · 60013-1804

Is this the product you have?

  • 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 Oaks Road, Cary, IL 60013
Lot codes and dates
  • Lot
    • 44385
    • Exp.06/16
  • Lot
    • 44669
    • Exp.12/15
Amount recalled
8-ct. 7,066 cases; 24-ct. 2,664 cases

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 8, 2016 · Data as of Sep 19, 7:19 PM UTC

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