Class II · Moderate risk
Rohto Cooling Eye Drops Digi Eye
Lack of Assurance of Sterility
Eye Drops Industrial Strength
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
CGMP Deviations: Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Manufactured for: Petragon, Inc., Edwardsville, KS 66111; b) SWIFT, Distributed by Swift First Aid, Inc., Valencia, Calif. 91355, UPC: 6 69635 24082 5; c) Xpect First aid, Manufactured for Cintas First Aid & Safety, Mason, OH 45040; d) ZEE, Distributed by ZEE MEDICAL, INC., Irvine, CA 92606, UPC: 6 90689 00609 9.
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-0322-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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
Rohto Cooling Eye Drops ALL-IN-ONE
Lack of Assurance of Sterility
Class II · Moderate risk
Sterile Eye Drops ORIGINAL FORMULA
Lack of Assurance of Sterility
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 2014 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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