FDA Medical Device Recalls (openFDA)
Apothecary Products, LLC: Medicine Dropper, Product Code K508
- Recall number
- Z-1703-2023
- Recalling firm
- Apothecary Products, LLC
- Product
- Medicine Dropper, Product Code K508
- Status
- Open, Classified
- Initiated
- 2023-03-30
- Posted
- 2023-06-09
- Terminated
- not on file
- Reason
- Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.
- Root 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
- 1,596 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.
- Lot, serial or model codes
- Lot Number: 021623; UPC Number: 077602005085
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KCM
- Firm FEI
- 2183416
- Firm city
- Burnsville
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28