Product Quest manufacturing, which recently announced a recall of CVS Health 12 Hour Sinus Relief Nasal Mist oxymetazoline nasal spray due to contamination with Pseudomonas aeruginosa, has now recalled all of the nasal products it manufactured at its Florida facility “out of an abundance of caution.”
The company provided a 63-page document listing over1,000 affected lots of various nasal products. The majority of the products are saline nasal sprays, including almost 300 lots of Ocean brand 2-packs with a 1.5 oz and a 0.76 oz bottle in each and over 300 lots of Ocean 3.5 oz bottles. Ocean brand nasal spray is distributed by Bausch Health (formerly Valeant), which acquired the brand in 2012.
The recall list includes products sold under more than a dozen brand names, including those of major US retailers such as CVS, Walgreens, Rite Aid, Rexall, Meijer, Family Dollar, and Dollar General.
Product Quest said that it has not received notice of any adverse events related to the recall.
In addition to the microbial contamination problem at its Florida facility, Product Quest received a warning letter from the FDA in April 2018 regarding GMP violations at its North Carolina facility, where the company manufactured pharmaceuticals and pesticides on the same equipment
Read the Product Quest press release.
