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Recall Observatory FDA recall evidence

Drug product

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.

D-1825-2019

July 26, 2019

Class II

Product summary

Firm
Medtech Products, Inc.
Event
Event 83417
Status
Terminated
Classification
Class II
Quantity
1,872,984 bottles
Official record key
drug-enforcement:D-1825-2019

Official wording

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.

Code information: Lot #: 16234, 16247, Exp 08/19; 16286, Exp 10/19; 16314, Exp 11/19

Distribution pattern: Nationwide in the USA and Puerto Rico, St. Michael, Barbados, Guyana, St. Johns, Antigua and Barbuda, Kingston 5, and Jamaica.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations