CLASS II Drug recall · Reported 24 Oct 2018 · FDA Enforcement Report
CVS Health, Saline Nasal Spray recalled by Product Quest Manufacturing
Product Quest Manufacturing is recalling CVS Health, Saline Nasal Spray, distributed nationwide in the US. The recall was initiated on 3 Aug 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0035-2019
- FDA event ID
- 80750
- Recalling firm
- Product Quest Manufacturing, Daytona Beach, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Aug 2018
- FDA classified
- 16 Oct 2018
- Reported
- 24 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Nasal Sprays
Timeline
| 3 Aug 2018 | Recall initiated by company | |
| 16 Oct 2018 | Classified by FDA | +74 days |
| 24 Oct 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Product as listed by the FDA
CVS Health, Saline Nasal Spray, 1.5 FL OZ bottle, Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, Product #277790.
Where it was distributed
Nationwide in the USA
Stores named: CVS
Questions about this recall
Why was it recalled?
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Which lots are affected?
All lots remaining within expiry.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
53 other products · FDA event 80750This product is part of a recall event; the main page for the event is Thayers Natural Remedies, Saline Nasal Spray recalled.
More recalls from Product Quest Manufacturing
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rhinall (phenylephrine hydrochloride) Nasal Decongestant recalled | Product Quest Manufacturing | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | CVS Health, Original Strength recalled by Product Quest Manufacturing | Product Quest Manufacturing | Potency & Assay | Nationwide |
| Drug | CLASS II | Rite Aid Pharmacy, nasal relief NO Drip Pump Spray nasal recalled | Product Quest Manufacturing | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Premier Value, Sterile Saline Nasal Mist recalled | Product Quest Manufacturing | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Well at Walgreens, Ultra Fine Sinus Relief Mist recalled | Product Quest Manufacturing | Manufacturing (CGMP) Deviations | Nationwide |
Other Cvs Health recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cvs Health, Magnesium Citrate Saline Laxative recalled by Vi-Jon | Vi-Jon | Sterility | Nationwide |
| Drug | CLASS III | CVS Health, Allergy Relief recalled by Dr. Reddy's Laboratories | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | CVS Health, Original Strength recalled by Product Quest Manufacturing | Product Quest Manufacturing | Potency & Assay | Nationwide |
| Drug | CLASS II | CVS Health, Baby Nasal Spray/Drops, Non-Medicated recalled | Product Quest Manufacturing | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby recalled | Product Quest Manufacturing | Manufacturing (CGMP) Deviations | Nationwide |