Reported Aug 28, 2019 · Terminated
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, packaged in a) 0.5 FL OZ (15…
Medtech Products, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtech Products, Inc. · 660 White Plains Rd Ste 250 · Tarrytown, NY · 10591-5171
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6) |
| 2 | 1 FL OZ (30 mL) bottle (UPC 6 78112 25419 4) |
| 3 | 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. |
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 16195, Exp 07/19; 16211, 16216, Exp 08/19 2 16205, Exp 07/19; 16211, Exp 08/19 3 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 - Amount recalled
- 6,661,188 bottles
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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