D-1826-2019 Class II Terminated
FDA drug recall D-1826-2019 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: 20,808 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
- 20,808 bottles
Product Description
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.
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 #: Display 17E23A, Exp 12/19; lot and expiry for individual products within this display are captured in each individual product Code Information