Drug product
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); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 66577 8); and c) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 65920 3); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, display UPC 6 78112 10452 9.
D-1826-2019
Product summary
- Event
- Event 83417
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,808 bottles
- Official record key
drug-enforcement:D-1826-2019
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 17E23A, Exp 12/19; 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