Drug product
Clear Eyes Redness Relief Hand Pocket Pal Tray Display; each display (UPC 6 78112 25418 7) contains 48 each of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, 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.
D-1835-2019
Product summary
- Event
- Event 83417
- Status
- Terminated
- Classification
- Class II
- Quantity
- 314,112 bottles
- Official record key
drug-enforcement:D-1835-2019
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 #: 17051, Exp 02/20; 17130, Exp 04/20; 17147, Exp 05/20
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