Key takeaways:
- Eight eye drop products have been recalled.
- The recall is class II, indicating adverse effects are temporary or unlikely to be serious.
K.C. Pharmaceuticals is recalling more than 3.1 million bottles of eye drops due to “lack of assurance of sterility,” according to the FDA.
The eight affected products, totaling 3,111,072 individual units, have been distributed throughout the U.S.
“K.C. Pharmaceuticals is recalling more than 3.1 million bottles of eye drops due to “lack of assurance of sterility.”
It is a class II recall, meaning the drops may cause temporary or reversible adverse effects, or have a low probability of causing severe adverse effects.
The following products have been recalled:
- 1,023,096 bottles of Dry Eye Relief Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%);
- 589,848 bottles of Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%);
- 378,144 bottles of Sterile Eye Drops Original Formula (tetrahydrozoline HCl 0.05%);
- 315,144 bottles of Sterile Eye Drops Redness Lubricant (glycerin 0.25%, naphazoline HCl 0.012%);
- 303,216 bottles of Eye Drops Advanced Relief (dextran 70 0.1%, polyethylene glycol 400 1%, tetrahydrozoline HCl 0.05%);
- 245,184 bottles of Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%);
- 182,424 bottles of Sterile Eye Drops AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%); and
- 74,016 bottles of Sterile Eye Drops Soothing Tears (polyethylene glycol 400 0.4%, propylene glycol 0.3%).
The products were distributed by companies including Walgreens, Kroger, CVS and Rite Aid.
Read more: K.C. Pharmaceuticals recalls more than 3 million eye drop bottles
Source: Healio