Drug product
Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 66577 8.
D-1825-2019
Product summary
- Event
- Event 83417
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,872,984 bottles
- Official record key
drug-enforcement:D-1825-2019
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 #: 16234, 16247, Exp 08/19; 16286, Exp 10/19; 16314, Exp 11/19
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