Recall Z-1703-2023 ยท KCM Dropper, Ent
Apothecary Products, LLC
Medicine Dropper, Product Code K508
| Date | Jun 9, 2023 (initiated Mar 30, 2023) |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.