D-0048-2019 Class II Terminated
FDA drug recall D-0048-2019 was initiated by Product Quest Manufacturing LLC on Aug 3, 2018 and is designated Class II. Reason for recall: CGMP Deviations: products manufactured under conditions that could impact its product quality. The recall status is terminated (terminated Mar 30, 2021). Affected quantity: 102,348 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 24, 2018
- Initiation Date
- Aug 3, 2018
- Termination Date
- Mar 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 102,348 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
All lots remaining within expiry.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0048-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026