Drug product
Clear Eyes Maximum Redness and Itchy Eye Relief Sidekick Display; each display contains 12 each of a) 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); and b) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 65920 3); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, case UPC 00678112105434.
D-1827-2019
Product summary
- Event
- Event 83417
- Status
- Terminated
- Classification
- Class II
- Quantity
- 66,168 bottles
- Official record key
drug-enforcement:D-1827-2019
Official wording
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.
Code information: Lot #: Display 17C30A, Exp 10/19; lot and expiry for individual products within this display are captured in each individual product Code Information
Distribution pattern: Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations