FDA (Drugs) recall action 98533
The FDA (Drugs) publishes a recall like this one as 8 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 8 pages.
Lack of Assurance of Sterility
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.
GNP Eye Drops Redness and Dry Eye Relief, containing glycerin and naphazoline hydrochloride, are being recalled for lack of assurance of sterility.
Leader Ultra Lubricating Eye Drops, containing polyethylene glycol 400 and propylene glycol, are being recalled for lack of assurance of sterility.
Quality Choice Eye Drops Irritation Relief, containing tetrahydrozoline HCl and zinc sulfate, are being recalled for lack of assurance of sterility. 182,424 bottles are affected.
K.C. Pharmaceuticals is recalling Sterile Eye Drops Soothing Tears, sold as Rugby Lubricating Eye Drops and Walgreens Lubricant Eye Drops, for lack of assurance of sterility.
Quality Choice Moisturizing Relief Eye Drops, containing dextran 70, polyethylene glycol 400, povidone and tetrahydrozoline hydrochloride, are being recalled for lack of assurance of sterility.
GoodSense Eye Drops Original Formula, containing tetrahydrozoline hydrochloride, are being recalled for lack of assurance of sterility.
Leader Artificial Tears 15 mL, containing polyvinyl alcohol and povidone, are being recalled for lack of assurance of sterility.
Artificial Tears containing glycerin are being recalled for lack of assurance of sterility. About 1,023,096 bottles were distributed nationwide.