FDAJuly 26, 2019drug
Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, UPC 6 78112 66577 8.
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
678112665778
Recall history
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- FDAHydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T32026-04-24
- FDAPremier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.2026-04-14
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