D-1824-2019 Class II Terminated
FDA drug recall D-1824-2019 was initiated by Medtech Products, Inc. on July 26, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated March 10, 2021). Affected quantity: 927,108 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 28, 2019
- Initiation Date
- July 26, 2019
- Termination Date
- March 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 927,108 bottles
Product Description
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, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 65920 3.
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
Code Information
Lot #: 16302, Exp 11/19; 16331, 16344, Exp 12/19; 17011, 17016, Exp 01/20.