PlainRecalls
FDA Drug Critical Class I Terminated

Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5.

Reported: October 24, 2018 Initiated: August 3, 2018 #D-0074-2019

Product Description

Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5.

Reason for Recall

Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.

Details

Units Affected
16 bottles
Distribution
Nationwide in the USA
Location
Daytona Beach, FL

Frequently Asked Questions

What product was recalled?
Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5.. Recalled by Product Quest Manufacturing LLC. Units affected: 16 bottles.
Why was this product recalled?
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 24, 2018. Severity: Critical. Recall number: D-0074-2019.