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Clear Eyes Redness Relief Pocket Pal (Medtech) - Quality Control Issues (2019)

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.

Class IIModerate

FDAJul 26, 2019Nationwide• Medtech Products, Inc.

Clear Eyes Maximum Itchy Relief (Medtech) - Quality Control Issues (2019)

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.

Class IIModerate

FDAJul 26, 2019

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Clear Eyes Redness Relief Pocket Pal (Medtech) - Quality Control Issues (2019)

Clear Eyes Maximum Itchy Relief (Medtech) - Quality Control Issues (2019)

Clear Eyes Assorted IRC (Medtech) - Quality Control Issues (2019)

Clear Eyes Redness Relief (Medtech) - Quality Control Issues (2019)

Clear Eyes Maximum Redness Relief (Medtech) - Quality Control Issues (2019)

Clear Eyes Redness Relief (Medtech) - Quality Control Issues (2019)

Clear Eyes Assorted Sidekick (Medtech) - Quality Control Issues (2019)

Clear Eyes Maximum Itchy Relief (Medtech) - Quality Control Issues (2019)

Clear Eyes Redness Relief Club Pack (Medtech) - Quality Control Issues (2019)

Clear Eyes Maximum Redness Relief Club Pack (Medtech) - Quality Control Issues (2019)

Clear Eyes Maximum Itchy Relief (Medtech) - Quality Control Issues (2019)

BOB Jogging Stroller Axles (Britax) – safety modification (2019)

Steps Bouncers (Stokke) – fall hazard (2019)

Head and Neck Support (Boppy) – suffocation risk (2019)

Travel Lite Sunnyside Lotion Wipe (LA FRESH) – Unapproved Sunscreen (2019)

Wintergreen Essential Oil (Nature's Truth) – Safety Closure (2019)

Ultra-Lite Play Yard Sleeper (Fisher-Price) – safety concern (2019)

Diphenhydramine HCL Liquid (Pharma Pac) – microbial contamination (2019)

Army Health Curcumin Pain Reliever (Pharma-Natural) – CGMP Deviation (2019)

GENCONTUSS Medication (Pharma-Natural) – manufacturing deviation (2019)