Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Clear Eyes Redness Relief Club Pack Display
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
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
Clear Eyes Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10552 6) of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (individual bottle UPC 6 78112 25415 6); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.
Drug: Naphazoline Category: Eye Drops & Ophthalmic
- Recalling firm
- Medtech Products, Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1829-2019 · 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 Naphazoline recalls
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Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Cool Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Optic Glow
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Max Strength
Lack of Assurance of Sterility
Other recalls by Medtech Products, Inc.
All 2019 recalls
Class II · Moderate risk
Clear Eyes Redness Relief Hand Pocket Pal Tray Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear eyes REDNESS RELIEF
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Class II · Moderate risk
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
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