Class II · Moderate risk
Rohto Cooling Eye Drops Digi Eye
Lack of Assurance of Sterility
Eye Drops advanced relief
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG 400, and povidone.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic solution, 1/2 fl oz (15 mL) bottle, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072.
Drug: Tetrahydrozoline Category: Eye Drops & Ophthalmic
- Recalling firm
- K C Pharmaceuticals Inc
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-192-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Tetrahydrozoline recalls
See all
Class II · Moderate risk
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Lack of Assurance of Sterility
Class II · Moderate risk
Sterile Eye Drops ORIGINAL FORMULA
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Class II · Moderate risk
EYE DROPS Advanced Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile EYE DROPS AC
Lack of Assurance of Sterility
Other recalls by K C Pharmaceuticals Inc
All 2010 recalls
Class II · Moderate risk
Artificial Tears Sterile Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile Eye Drops Soothing Tears
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile EYE DROPS REDNESS LUBRICANT
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile Eye Drops ORIGINAL FORMULA
Lack of Assurance of Sterility
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