CVS Sinus Relief Nasal Spray Recalled for Pseudomonas Contamination
Product Quest Manufacturing LLC is recalling CVS-branded Sinus Relief nasal spray due to failed microbiological testing for Pseudomonas aeruginosa.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
Product Quest Manufacturing LLC is recalling 16 bottles of Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottles. The product is distributed by CVS Pharmacy, Inc., and carries the UPC 0 50428 43236 5. The specific lot number is 173089J with an expiration date of 09/19.
The recall was initiated because the product failed microbiological testing for Pseudomonas aeruginosa. This is a non-sterile product that was found to be contaminated with this specific microbe. The recall is classified as Class I by the FDA.
The affected product was distributed nationwide in the USA. Consumers who have this specific lot of the nasal spray should stop using it and contact the distributor or manufacturer for further instructions.
The recalled product
- 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.
- Manufacturer
- Product Quest Manufacturing LLC
- Category
- Drug — Nasal Decongestant
- Affected units
- 16
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 173089J Exp. 09/19
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 recalled by Product Quest Manufacturing LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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