Premier Value — Class II drug recall D-0048-2019
Terminated recall by Product Quest Manufacturing LLC, reported 2018-10-24, distributed nationwide. CGMP Deviations: products manufactured under conditions that could impact its product quality.
| Recall number | D-0048-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Product Quest Manufacturing LLC, Daytona Beach, FL, United States |
| Recall initiated | 2018-08-03 |
| Classified | 2018-10-16 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2021-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 102,348 bottles |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00840986014826, 00840986014833 |
| NDC | 68016-0388-00, 68016-0466-00 |
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 for recall
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0048-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.