More than 3 million bottles of eye drops recalled over safety concerns, FDA says

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A pharmaceutical company has issued a voluntary recall of over 3 million of its over-the-counter eye-drop products after the Food and Drug Administration cited a “lack of assurance of sterility.”

According to the FDA notice, K.C. Pharmaceuticals, of Pomona, California, manufactures the products for a number of brands sold under names such as “Dry Eye Relief Eye Drops,” “Sterile Eye Drops” and “Artificial Tears Sterile Lubricant Eye Drops.” The recall of 3,111,072 bottles began in early March.

The eye drops are sold at major retailers, including CVS, Walgreens and Rite Aid.

There aren’t reports of injuries associated with the eye drops yet. The FDA notice classified the action as a “Class II recall.” Class II recalls apply to products that can cause “temporary or medically reversible” health problems.

People can continue using their medication during a Class II recall unless stated otherwise by the company, according to the FDA.

It’s unclear what triggered the recall. K.C. Pharmaceuticals didn’t immediately reply to NBC News’ request for comment.

The recalled products are:

  • Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl oz (15 mL) bottles
  • EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 fl oz (15 mL) bottles
  • Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 fl oz (15 mL) bottles
  • Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 fl oz (15mL) bottles
  • Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%), 0.5 fl oz (15mL) bottles
  • Sterile Eye Drops Redness Lubricant (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles
  • Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4% and propylene glycol 0.3%), 0.5 OZ 0.5 fl oz (15 mL) bottles
  • Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 fl oz (15 mL) bottles



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