FDA Medical Device Recalls (openFDA)
GSK Consumer Healthcare: Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
- Recall number
- Z-2148-2016
- Recalling firm
- GSK Consumer Healthcare
- Product
- Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
- Status
- Terminated
- Initiated
- 2016-04-25
- Posted
- 2016-07-11
- Terminated
- 2017-07-19
- Reason
- Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips were incorrectly labeled for cartons intended for the AU/NZ market.
- Root cause
- Error in labeling
- Action
- GSK Consumer Healthcare sent an Urgent - Product Recall Letter dated April 4, 2016, to all affected customers and an updated recall letter dated April 25, 2016, via FedEx. The recall letters identified the product and problem. The April 25, 2016, was sent to further clarify, the lot number on the Breathe Right carton. The customers were asked to immediately examine their inventory, quarantine and cease distribution of the specific lot of the affected product. Customers were asked to carry out a physical count and record the data on the response form. The response form should be returned to GSK within five (5) business days, even if you do not have the recalled lot. The response form should be faxed to (336) 499-8795. If customer needs shipping assistance or questions about the recall process, they can call 1-844-722-2104, and refer to Event Number 535STRIPS16. If any customer has questions, they can direct them to GSK Consumer Healthcare Consumer Relations team at 800-858-6673.
- Quantity
- 1,440 cases ( 34, 560 retail - units )
- Distribution
- US Nationwide
- Lot, serial or model codes
- Shipper case lot #8008580, Retal Carton Lot #4543U8008580
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 3012293198
- Firm city
- Warren
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28