FDA Recall D-0074-2019
Product Quest Manufacturing LLC · Daytona Beach, FL
Class I — life-threatening Terminated 970 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-0074-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2018-08-03
- Classified by FDA Center
- 2018-10-16
- FDA published
- 2018-10-24
- Terminated
- 2021-03-30
- Recalling firm
- Product Quest Manufacturing LLC
- Firm location
- Daytona Beach, FL