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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
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
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
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FDA (Drugs) · 2016-12-28
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FDA (Drugs) · 2014-09-10
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Similar recalls
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FDA (Drugs) · 2014-09-10
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