FDA Drug Moderate Class II Terminated

CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt. 1.52 OZ (43 g) can UPC 0 50428 37079 7 Product #896831; b) Net Wt. 4.25 OZ (120 g) can UPC 0 50428 36124 5; c) Children's Net Wt. 2 OZ (57 g) can UPC 0 50428 58685 3 Product #282472, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.

Reported: October 24, 2018 Initiated: August 3, 2018 #D-0030-2019

Product Description

CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt. 1.52 OZ (43 g) can UPC 0 50428 37079 7 Product #896831; b) Net Wt. 4.25 OZ (120 g) can UPC 0 50428 36124 5; c) Children's Net Wt. 2 OZ (57 g) can UPC 0 50428 58685 3 Product #282472, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.

Reason for Recall

CGMP Deviations: products manufactured under conditions that could impact its product quality.

Details

Recalling Firm: Product Quest Manufacturing LLC
Units Affected: 529,536 cans
Distribution: Nationwide in the USA
Location: Daytona Beach, FL

Frequently Asked Questions

What product was recalled? ▼

CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt. 1.52 OZ (43 g) can UPC 0 50428 37079 7 Product #896831; b) Net Wt. 4.25 OZ (120 g) can UPC 0 50428 36124 5; c) Children's Net Wt. 2 OZ (57 g) can UPC 0 50428 58685 3 Product #282472, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.. Recalled by Product Quest Manufacturing LLC. Units affected: 529,536 cans.

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-0030-2019.

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