The Recall Desk
CriticalFDA (Drugs)·D-0074-2019·Announced 2018-10-24

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
Hazard
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.

See all 54 products in this recall →

Related recalls

Same manufacturer · Product Quest Manufacturing LLC

See all →

Same hazard · pseudomonas aeruginosa

See all →