Summary
The FDA issued a Class III for Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496 by Boothwyn Pharmacy LLC. Reason: Subpotent Drug.
Details
Source
Drug Recall
External ID
D-0607-2025
Action Date
2025-09-10
Status
Ongoing
Category
drug
Product Description
Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
Lot/Code Info: 06092025@23 BUD 09/09/2025
Quantity Affected: 8 vials
Reason for Recall
Subpotent Drug
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-09
Company
Kennett Square, PA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Boothwyn Pharmacy LLC has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Boothwyn Pharmacy LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boothwyn Pharmacy LLC have FDA actions?
Boothwyn Pharmacy LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0607-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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