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Recall Observatory FDA recall evidence

Drug product

Clear Eyes Maximum Redness Relief Club Pack Display; each display contains 18 3-Pack bottles (UPC 6 78112 10859 6) of Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%) eye drops, 0.5 FL OZ (15 mL) bottle, (UPC 6 78112 66577 8); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company.

D-1831-2019

July 26, 2019

Class II

Product summary

Firm
Medtech Products, Inc.
Event
Event 83417
Status
Terminated
Classification
Class II
Quantity
17,316 bottles
Official record key
drug-enforcement:D-1831-2019

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 #: Q16322M1, Q16323M1, Q16323M2, Q16326M1, Exp 08/19; lot and expiry for individual products within this display are captured in each individual product Code Information

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