FDA Drug recall D-1822-2019
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 7811…
- FDA Drug
- Class II
- terminated
- Published 2019-08-28
On 2019-08-28 the FDA classified a Class II recall of Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 7811… 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-1822-2019 |
| 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 REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) 1 FL OZ (30 mL) bottle (UPC 6 78112 25419 4); c) 0.2 FL OZ (6 mL) bottle, Handy Pocket Pal (UPC 6 78112 25418 7); Distributed by Medtech Products Inc., Tarrytown, NY 10591; A Prestige Brands Company.
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 | 678112254156 |
|---|---|
| upc | 678112254194 |
| upc | 678112254187 |
| code_info | Lot #: a) 16195, Exp 07/19; 16211, 16216, Exp 08/19; b) 16205, Exp 07/19; 16211, Exp 08/19; c) 16192, 16203, Exp 07/19;…Lot #: a) 16195, Exp 07/19; 16211, 16216, Exp 08/19; b) 16205, Exp 07/19; 16211, Exp 08/19; c) 16192, 16203, Exp 07/19; 16242, Exp 09/19; 16280, 16285, Exp 10/19; 16300, Exp 11/19; 16336, Exp 12/19; 17002, 17012, Exp 01/20; 17051, Exp 02/20; 17130, Exp 04/20; 17147, Exp 05/20 |
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-1822-2019%22
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