FDA Drug recall D-0048-2019
Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986 01483 3
- FDA Drug
- Class II
- terminated
- Published 2018-10-24
On 2018-10-24 the FDA classified a Class II recall of Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986 01483 3 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-0048-2019 |
| 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
Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986 01483 3; b) 1.5 FL OZ (44 mL) bottle NDC 68016-466-00 UPC 8 40986 01482 6, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431.
Reason
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Identifiers
| upc | 840986014833 |
|---|---|
| upc | 840986014826 |
| 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-0048-2019%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.