Additional Coverage:
- Eye drops recalled over safety concerns, FDA says (nbcnews.com)
A pharmaceutical manufacturer based in Pomona, California, has initiated a voluntary recall of more than three million bottles of over-the-counter eye-drop products. The action follows an FDA notification citing concerns over the inability to guarantee product sterility.
K.C. Pharmaceuticals produces these eye drops under various brand names, including “Dry Eye Relief Eye Drops,” “Sterile Eye Drops,” and “Artificial Tears Sterile Lubricant Eye Drops.” The recall, which began in early March, affects 3,111,072 bottles distributed nationwide and sold through major retail chains such as CVS, Walgreens, and Rite Aid.
Currently, there have been no reported injuries linked to the use of the recalled products. The FDA has classified this as a Class II recall, indicating that while the products may cause temporary or medically reversible health issues, they are not expected to pose serious harm. Customers are advised that they may continue using the eye drops unless otherwise directed by the manufacturer.
Details surrounding the cause of the recall remain unclear, and K.C. Pharmaceuticals has not provided additional comments on the matter.
The recalled items include the following formulations, all in 0.5 fluid ounce (15 mL) bottles:
- Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%)
- EYE DROPS Advanced Relief (dextran 70 0.1%, polyethylene glycol 400 1%, tetrahydrozoline HCl 0.05%)
- Dry Eye Relief Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%)
- Ultra Lubricating Eye Drops Sterile (polyethylene glycol 400 0.4%, propylene glycol 0.3%)
- Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%)
- Sterile Eye Drops Redness Lubricant (glycerin 0.25%, naphazoline HCl 0.012%)
- Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4%, propylene glycol 0.3%)
- Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%)
Consumers in possession of these products should monitor for any unusual symptoms and consult healthcare professionals if concerns arise. Retailers and distributors are expected to remove affected products from shelves promptly.
Read More About This Story:
- Eye drops recalled over safety concerns, FDA says (nbcnews.com)