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.
Reported: October 24, 2018 Initiated: August 3, 2018 #D-0048-2019
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.
Details
- Recalling Firm
- Product Quest Manufacturing LLC
- Units Affected
- 102,348 bottles
- Distribution
- Nationwide in the USA
- Location
- Daytona Beach, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Product Quest Manufacturing LLC. Units affected: 102,348 bottles.
Why was this product recalled? ▼
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 24, 2018. Severity: Moderate. Recall number: D-0048-2019.
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