The Recall Desk
HighFDA (Drugs)·D-1573-2014·Announced 2014-09-10

Sage Recalls Comfort Shield Barrier Cream Cloths Due to Bacterial Contamination

Sage Products Inc. is recalling Comfort Shield Barrier Cream Cloths because packages tested positive for bacterial contamination.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk pathogen (bacterial contamination) without reported illness, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Sage Products Inc. is recalling specific packages of Comfort Shield Barrier Cream Cloths. The recall is being conducted because the products tested positive for bacterial contamination.

The affected products are Comfort Shield Barrier Cream Cloths containing dimethicone. The recall includes 8-count packages (NDC 53462-915-80) and 24-count packages (NDC 53462-915-60). The specific lots involved are Lot 44385 (Expiration 06/16) and Lot 44669 (Expiration 12/15). The products were distributed nationwide.

Consumers should stop using the affected products and return them to the place of purchase for a refund or follow the instructions provided by the recalling firm.

The recalled product

Product
COMFORT SHIELD BARRIER (DIMETHICONE)
Brand
COMFORT SHIELD BARRIER
Manufacturer
Sage Products Inc
Category
Drug — OTC Topical
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 (4)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · COMFORT SHIELD BARRIER

Same manufacturer · Sage Products Inc

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Same hazard · bacterial contamination

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