Breathe Right Clear Nasal Strips Recalled for Incorrect Packaging Labels
GSK Consumer Healthcare is recalling Breathe Right Clear nasal strips because some secondary packaging cartons were incorrectly labeled for the AU/NZ market.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging labeling error rather than a product defect or contamination.
Plain-English summary
GSK Consumer Healthcare is recalling Breathe Right Clear, Large, 30 ct. Nasal Strips. The recall involves 1,440 cases, which equates to 34,560 retail units, distributed nationwide in the US.
The recall was initiated because some cartons used in the secondary packaging were incorrectly labeled for cartons intended for the AU/NZ market. The affected product is identified by Shipper case lot #8008580 and Retail Carton Lot #4543U8008580. The US UPC is 7-57145-00246-7 and the AU/NZ UPC is 9-300673-871749.
Consumers who have purchased this product should check their packaging for the specific lot numbers listed above. If the lot numbers match, consumers should stop using the product and contact GSK Consumer Healthcare for further instructions.
The recalled product
- Product
- Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
- Manufacturer
- GSK Consumer Healthcare
- Category
- Consumer Product — Nasal Strips
- 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 (2)
- Shipper case lot #8008580
- Retal Carton Lot #4543U8008580
Distribution
Distributed nationwide across the United States.
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