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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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.
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FDA (Drugs) · 2016-12-28
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Similar recalls
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