Recall Z-2148-2016— GSK Consumer Healthcare
Class III · Terminated
Class III FDA medical device recall by GSK Consumer Healthcare, initiated 2016-04-25, terminated 2017-07-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ). 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..
- Recalling firm
- GSK Consumer Healthcare
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-04-25
- Terminated
- 2017-07-19
- Firm location
- Warren, NJ, United States
Product description
Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.