FDA Drug recall D-1824-2019
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) bot…
- FDA Drug
- Class II
- terminated
- Published 2019-08-28
On 2019-08-28 the FDA classified a Class II recall of 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) bot… by Medtech Products, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1824-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-26 |
| Published | 2019-08-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Medtech Products |
| Distribution | US |
Product
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
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.
Identifiers
| upc | 678112659203 |
|---|---|
| code_info | Lot #: 16302, Exp 11/19; 16331, 16344, Exp 12/19; 17011, 17016, Exp 01/20. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1824-2019%22
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