Severity
Moderate
FDA Drug recall · Reported October 24, 2018
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product Quest Manufacturing LLC recalled CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.2… - a moderate-severity action.
CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.2… was recalled by Product Quest Manufacturing LLC in October 24, 2018. Reason: CGMP Deviations: products manufactured under conditions that could impact its product quality.. Check the official notice for the remedy. Verify recall #D-0032-2019 with the FDA Drug before acting.
The recall
Product Quest Manufacturing LLC issued this moderate-severity FDA Drug recall-CGMP Deviations: products manufactured under conditions that could impact its product quality..
Sourced from official FDA Drug enforcement records. Verify recall #D-0032-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0032-2019) was formally reported on October 24, 2018, with the manufacturer initiating the action on August 3, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Product Quest Manufacturing LLC is listed as the recalling firm, operating out of Daytona Beach, FL. Federal records list the affected scope as 277,587 cans.
The documented reason for this recall is: CGMP Deviations: products manufactured under conditions that could impact its product quality. Distribution data in the federal record shows the product reached: Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
277,587 cans
Related Recalls
6
5 from same agency
CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.25 OZ (126 g) can, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 41854 3.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0032-2019 |
| Date reported | October 24, 2018 |
| Date initiated | August 3, 2018 |
| Recalling firm | Product Quest Manufacturing LLC |
| Firm location | Daytona Beach, FL |
| Affected scope | 277,587 cans |
| Distribution | Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Lupin Pharmaceuticals Inc. · 2026-05-27
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported October 24, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.