Summary
The FDA issued a Class II for Medicine Dropper, Product Code K508 by Apothecary Products, LLC. Reason: Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb..
Details
Source
Device Recall
External ID
Z-1703-2023
Action Date
2023-06-21
Status
Ongoing
Category
device
Product Description
Medicine Dropper, Product Code K508
Lot/Code Info: Lot Number: 021623; UPC Number: 077602005085
Quantity Affected: 1,596 units
Reason for Recall
Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-30
Company
Burnsville, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Apothecary Products, LLC has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Apothecary Products, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Apothecary Products, LLC have FDA actions?
Apothecary Products, LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1703-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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