Key Takeaway
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) 1 FL OZ (30 mL) bottle (UPC 6 78112 25419 4); by Medtech Products, Inc. was recalled on July 26, 2019. The hazard: CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impac...
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) 1 FL OZ (30 mL) bottle (UPC 6 78112 25419 4);
Description
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) 1 FL OZ (30 mL) bottle (UPC 6 78112 25419 4); c) 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech Products Inc., Tarrytown, NY 10591; A Prestige Brands Company.
Hazard / Reason
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: Product that may cause temporary or medically reversible health consequences.
Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.
Products Affected
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) 1 FL OZ (30 mL) bottle (UPC 6 78112 25419 4);
DrugsCompany Information
Medtech Products, Inc.
Irvington, NY, United States
View all 18 recalls by Medtech Products, Inc. →Distribution
Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
Related Recalls
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Distributed by Select Corporation, Carrolton, TX 75007; Medtech Prod
July 26, 2019
Clear Eyes Redness Relief Handy Pocket Pal Club Pak Display; each display (case UPC 30300742541283) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye
July 26, 2019
Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6
July 26, 2019
Clear Eyes Assorted Sidekick Floor Stand Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UP
July 26, 2019
Clear Eyes Maximum Itchy Eye Relief Sidekick Floor Stand Display; each display (case UPC 10678112736383) contains 12 each of Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochlor
July 26, 2019
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
July 26, 2019
Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.