The Recall Desk
CriticalFDA (Drugs)·D-0229-2017·Announced 2016-12-28

Sage Products Recalls Comfort Shield Barrier Cream Cloths Due to Bacteria

Sage Products LLC is recalling Comfort Shield Barrier Cream Cloths because they are contaminated with Burkholderia cepacia bacteria.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Sage Products LLC is recalling Comfort Shield Barrier Cream Cloths, a dimethicone-based topical product, due to microbial contamination. The product is contaminated with the bacteria Burkholderia cepacia.

The recall affects 576,802 cases of the product, which were distributed nationwide and internationally to locations including Puerto Rico, the United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, the UK, Honduras, Ireland, Mexico, Malaysia, the Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador. Specific lot numbers and expiration dates are listed in the official recall documentation.

Consumers should stop using the affected products and contact the manufacturer for instructions on return or disposal.

The recalled product

Product
COMFORT SHIELD BARRIER (DIMETHICONE)
Brand
COMFORT SHIELD BARRIER
Manufacturer
Sage Products LLC
Category
Drug — Topical OTC
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • Lot #: a) 53957
  • Exp 03/06/18
  • b) 54769
  • Exp 04/22/18
  • 54922
  • Exp 05/03/18
  • 55781
  • Exp 06/19/18
  • c) 53095
  • Exp 07/13/17

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Sage Products LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same brand · COMFORT SHIELD BARRIER

Same manufacturer · Sage Products LLC

See all →

Same hazard · microbial contamination

See all →