Product Quest, the manufacturer of Ocean® Saline Nasal Spray, has requested that Valeant voluntarily recall at the retail level all lots of our Ocean® Saline Nasal Spray products manufactured at their facility. These products include all Ocean® Saline Nasal Spray products within expiration (1.5 fl. oz., 3.5 fl. oz. and a buddy pack consisting of a 0.76 fl. oz. bottle and a 1.5 fl. oz. bottle). Importantly, this voluntary recall does not include Ocean® Complete sinus rinse (6 fl. oz. canister), since it is produced by a different manufacturer. Ocean® Nasal Spray is used to treat dryness inside the nose (nasal passages) due to colds, allergies, dry eye, pollution, smoke, air travel and use of decongestant steroidal sprays.
Product Quest has requested that we voluntarily recall these products due to possible out-of-specification results related to microbial contamination - Pseudomonas aeruginosa (a gram-negative bacterium). Product Quest became aware of these findings following an internal quality review at their facility.
Although there has been no known reported microbial contamination associated with Ocean® Saline Nasal Spray, we are following Product Quest’s request to voluntarily recall this product out of an abundance of caution.
Please note that if certain patient populations, including those with cystic fibrosis or those who have compromised immune systems, frequently use a nasal spray containing gram-negative bacterium they could develop a life threatening infection.
At this time, we are unable to determine if or when Ocean® Saline Nasal Spray may return to the marketplace.
Ocean® Complete sinus rinse, which is not impacted by this voluntary recall, is still available and can be purchased at several retailers including Walmart and Amazon.
Lot Numbers: View all lots impacted here
UPC Codes: 301875260026 301875260019 301875260033
Please contact Stericycle, Inc., the firm managing this voluntary product recall on behalf of Valeant, for more information at 1-888-667-1502.Consumers:
For more information on this voluntary recall, consumers can contact Stericycle, Inc., the firm conducting this product recall on behalf of Valeant, at 1-888-667-1502.
Ocean® Complete sinus rinse, which is not impacted by this voluntary recall, is still available and can be purchased at several retailers including Walmart and Amazon. You can also consult your health care professional to determine what nasal spray may be best for you.
Ocean is a trademark of Valeant Pharmaceuticals North America LLC.
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