Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per ca
Summary
The FDA issued a Class III for Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1 by Imprimis NJOF, LLC. Reason: Sub-Potent Drug: Subpotent assay results during stability testing..
Details
Source
Drug Recall
External ID
D-0536-2025
Action Date
2025-07-30
Status
Completed
Category
drug
Product Description
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
Lot/Code Info: Lot: 25MAR032, Exp. 07/16/2025.
Quantity Affected: 2,890 vials
Reason for Recall
Sub-Potent Drug: Subpotent assay results during stability testing.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-09
Company
Ledgewood, NJ
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 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Imprimis NJOF, LLC has 20 FDA actions in our database, including 20 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 (Imprimis NJOF, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Imprimis NJOF, LLC have FDA actions?
Imprimis NJOF, LLC has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0536-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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