D-0030-2019 Class II Terminated
FDA drug recall D-0030-2019 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: 529,536 cans.
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
- 529,536 cans
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.
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-0030-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026