FDA (Drugs) recall action 97031
The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Zicam Nasal AllClear swabs are being recalled because of fungal contamination of the nasal swabs. All lots are affected, covering 13,632 cartons.
Zicam Cold Remedy Medicated Nasal Swabs are being recalled because of fungal contamination of the swabs. All lots are affected, covering 3,374,918 cartons.
Orajel Baby Cooling Swabs for Teething are being recalled because of fungal contamination of the infant oral swabs. All lots are affected, covering 695,880 cartons.