Recalls / Class II
Class IID-0032-2019
Product
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.
- Affected lot / code info
- All lots remaining within expiry.
Why it was recalled
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Recalling firm
- Firm
- Product Quest Manufacturing LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 330 Carswell Ave, N/A, Daytona Beach, Florida 32117-4416
Distribution
- Quantity
- 277,587 cans
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-08-03
- FDA classified
- 2018-10-16
- Posted by FDA
- 2018-10-24
- Terminated
- 2021-03-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0032-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.