FDA Drug Recalls

Recalls / Class II

Class IID-0057-2019

Product

Best Choice, 12 Hour Sinus Relief, Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co,. 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 63684 7.

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
1008 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-0057-2019. 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