Z-1702-2023Class II

Eye and Ear Dropper, Product Code 67082

Name: Z-1702-2023 Eye and Ear Dropper, Product Code 67082
Creator: Apothecary Products, LLC
Published: 2023-03-30
License: https://open.fda.gov/license/

Apothecary Products, LLC / initiated 2023-03-30 / Open, Classified / root cause: manufacturing process

FDA source

Apothecary Products, LLC began a recall of Eye and Ear Dropper, Product Code 67082 on 2023-03-30. FDA classified it as Class II and gives the reason as "Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1702-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-30
Posted: 2023-06-09
Recalling firm: Apothecary Products, LLC
Product: Eye and Ear Dropper, Product Code 67082
Product code: KCM Dropper, Ent
Reason for recall: Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: Lot Number: 030923; UPC Number: 025715670829

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1702-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1702-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-09
Z-1703-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-09

Product code KCM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)