FDAJuly 26, 2019drug

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 Produc...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

medtech productsmedtech

UPCs

678112254156678112254194678112254187

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 Produc... — Recall Details · AllClear