Haleon US HOLDINGS LLC
East Durham, NY, US
Haleon US HOLDINGS LLC appears in FDA device records in East Durham, NY. FDA records list no 510(k) clearances, no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Haleon US HOLDINGS LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- GSK Consumer Healthcareenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012293198 | 3012293198 | Haleon US HOLDINGS LLC | 184 LIBERTY CORNER RD, Warren, NJ 07059 US | 2026 | |
| 1314819 | 1314819 | Haleon US Holdings LLC | 3169 Route 145, East Durham, NY 12423 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2148-2016 | Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ) | 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. | Class III | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain