Sinus Relief Nasal decongestant recalled over sterility concerns
- Recall date
- August 3, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Product Quest Manufacturing LLC recalls Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc…
- Recall number
- D-0074-2019
- FDA classification
- Class I
- Brand / firm
- Product Quest Manufacturing LLC
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What 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.
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