Florida-based Product Quest Manufacturing has recalled a lot of CVS Health 12 Hour Sinus Relief Nasal Mist oxymetazoline nasal spray due to contamination with Pseudomonas aeruginosa. The company said that it had not received reports of any adverse events but acknowledged that use of a nasal spray contaminated with P. aeruginosa could potentially lead to deadly infections for patients with cystic fibrosis or compromised immune systems.
According to Product Quest, the lot number is 173089J, with an expiration date of September 2019. Almost 17,000 units were released and were distributed to CVS retail stores across the US.
An FDA warning letter issued to Product Quest in April 2018 cites “significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”
Among other things, the agency said that the company “manufactured topical human drugs and several pesticides in the same building, using shared equipment” and had no written procedures for cleaning the equipment. Products were found to contain pesticides and other impurities.
Read the Product Quest press release.
Read the FDA warning letter.
