Class 2 Device Recall Ezy Dose

• Date Initiated by Firm: March 30, 2023
• Date Posted: June 09, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1702-2023
• Recall Event ID: 92247
• Product Classification: Dropper, ent - Product Code KCM
• Product: Eye and Ear Dropper, Product Code 67082
• Code Information: Lot Number: 030923; UPC Number: 025715670829
• FEI Number: 2183416
• Recalling Firm/ Manufacturer: Apothecary Products, LLC; 11750 12th Ave S; Burnsville MN 55337-1297
• For Additional Information Contact: Bobbi Doyle; 952-808-8312
• Manufacturer Reason for Recall: Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.
• FDA Determined Cause: Process control
• Action: Apothecary Products notified customers on 03/31/2023 via email. Customers were instructed to immediately check inventory and discard the affected units, notify customers if further distributed, and complete and return the Customer Response Acknowledgement Notification.
• Quantity in Commerce: 2,346 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.