FDA Drug recall D-0055-2019
OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9
- FDA Drug
- Class II
- terminated
- Published 2018-10-24
On 2018-10-24 the FDA classified a Class II recall of OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9 by Product Quest Manufacturing, citing CGMP Deviations: products manufactured under conditions that could impact its product quality.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0055-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-03 |
| Published | 2018-10-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Product Quest Manufacturing |
| Distribution | US |
Product
OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9; b) 45 cc (1.5 fl. oz.) UPC 3 01875 26003 3, c) Buddy Pack containing one 1.5 FL. OZ. (44 mL) and one 0.76 FL.OZ. (22 mL) bottle per carton, Distributed by: Valeant Consumer Products, A Division of Valeant Pharmaceuticals, North America LLC, Bridgewater, NJ 08807.
Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Identifiers
| upc | 301875260019 |
|---|---|
| upc | 301875260033 |
| code_info | All lots remaining within expiry. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0055-2019%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.