FDA Drug recall D-1452-2016
Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk…
- FDA Drug
- Class II
- terminated
- Published 2016-08-10
On 2016-08-10 the FDA classified a Class II recall of Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk… by Let S Talk Health, citing marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1452-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-05 |
| Published | 2016-08-10 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Let S Talk Health |
| Distribution | US |
Product
Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914.
Reason
Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
Identifiers
| code_info | Lot #15522 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1452-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.