FDAFDA · Food and drugs·Recall number D-1834-2019
Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%) eye drops, Handy Pocket Pal, 0.2 FL OZ (6 mL) bottle, Distributed by Select Corporation, Carrolton, TX 75007; Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 55708 01039 6.
Published August 28, 2019 · Recall initiated: July 26, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtech Products, Inc.
- Distributor
- Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.
- Lot
- Lot #: 16192, 16203, Exp 07/19; 16321, Exp 11/19; 17002, Exp 01/20; 17034, Exp 02/20
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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