FDA Drug Recalls

Recalls / Class II

Class IID-0035-2019

Product

CVS Health, Saline Nasal Spray, 1.5 FL OZ bottle, Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, Product #277790.

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
552 bottles
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-0035-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.