Drug product
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Dist. by Lil' Drug Store Products Inc., 1201 Continental Place NE, Cedar Rapids, IA 52402; Medtech Products Inc., Tarrytown, NY 10591, UPC 7 92554 70103 7.
D-1823-2019
Product summary
- Event
- Event 83417
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,621,200 bottles
- Official record key
drug-enforcement:D-1823-2019
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 #: 16321, Exp 11/19; 16336, Exp 12/19; 17012, Exp 01/20; 17034, 17051, Exp 02/20; 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