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Recall Observatory FDA recall evidence

Device product

Eye and Ear Dropper, Product Code 67082

Z-1702-2023

March 30, 2023

Class II

Product summary

Firm
Apothecary Products, LLC
Event
Event 92247
Status
Ongoing
Classification
Class II
Quantity
2,346 units
Official record key
device-enforcement:Z-1702-2023

Official wording

Reason: Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.

Code information: Lot Number: 030923; UPC Number: 025715670829

Distribution pattern: Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, HI, IL, IN, MO, NC, NJ, NY, OK, OR, PA, TN, TX, UT, WA and the country of Canada.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate