Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10859 6) of Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Reason shortfill; reports of empty capsules.
Reason Presence of Particulate Matter: Hair was found in products
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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