Magonate

Voluntary Recall of All Lots of Ocean® Saline Nasal Spray

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. 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). 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.

VOLUNTARY RECALLED PRODUCT DETAILS

Product: Ocean® Saline Nasal Spray (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

Lot Numbers:    All Lots

UPC Codes:       301875260026
                            301875260019
                            301875260033

Wholesalers and Retailers:

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.

Moving forward, you may consider using another nasal spray on the market. You can also consult your health care professional to determine what nasal spray may be best for you.