FDA Drug Recalls

Recalls / Class II

Class IID-0041-2019

Product

meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL OZ (44 mL) UPC 7 08820 74428 8; b) 3FL OZ (88 mL) UPC 7 08820 74430 1, Dist. By Meijer Distribution, Inc., Grand Rapids, MI 49544 .

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
182,568 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-0041-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.