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OTC Drug Products (Dollar Tree) – Temperature Storage Violation (2023)

CGMP Deviations: OTC products were stored outside of labeled temperature requirements.

FDAOct 5, 2023Nationwide• Dollar Tree Distribution, Inc.

CareFusion Medication System (CareFusion) – Dispensing Error Risk (2023)

If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the RxVerify Validation Code be entered/without validation from a pharmacist, which could lead to unintended and incorrect medication removal.

High

FDAOct 5, 2023Nationwide• CareFusion 303, Inc.

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OTC Drug Products (Dollar Tree) – Temperature Storage Violation (2023)

CareFusion Medication System (CareFusion) – Dispensing Error Risk (2023)

Dentemp Dental Product (Family Dollar) – Temperature Storage Issue (2023)

Volkswagen Atlas (Volkswagen) – Side Airbag Weld Issue (2023)

Denture Cleanser (Family Dollar) – Temperature Storage Issue (2023)

FloTrac Sensor with VAMP (Edwards Lifesciences) – Flushing Difficulty (2023)

BD Insyte IV Catheter (Becton Dickinson) – Needle Retraction Issue (2023)

Dorman Ball Joint (Dorman) – Ball Stud Separation Risk (2023)

Acumen IQ Sensor (Edwards Lifesciences) – Flushing Difficulty (2023)

Allura Xper IGTS Systems (Philips) – Puerto Rico Delivery Issue (2023)

TruWave Pressure Monitoring Set (Edwards Lifesciences) – Flushing Difficulty (2023)

Azurion IGTS Systems (Philips) – Puerto Rico Delivery Issue (2023)

Veradius Unity C-arm (Philips) – Puerto Rico Delivery Issue (2023)

Zenition Mobile Surgery C-arm (Philips) – Puerto Rico Delivery Issue (2023)

Fixodent Adhesive (Family Dollar) – Temperature Storage Issue (2023)

Teeth Whitening Pen (Family Dollar) – Temperature Storage Issue (2023)

First Response Pregnancy Test (Family Dollar) – Temperature Storage Issue (2023)

TruWave Pressure Monitoring Set (Edwards Lifesciences) – Flushing Difficulty (2023)

FloTrac Sensor (Edwards Lifesciences) – Flushing Difficulty (2023)

Integris-Allura IGTS Systems (Philips) – Puerto Rico Delivery Issue (2023)