FDA Drug Recalls

Recalls / Class II

Class IID-0052-2019

Product

Thayers Natural Remedies, Saline Nasal Mist, Allergy & Sinus Relief, Slippery Elm, 3 FL OZ (89 mL) can, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00659 8.

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
16,944 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-0052-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls