MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% -
Summary
The FDA issued a Class III for MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Opht by Imprimis NJOF, LLC. Reason: Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim..
Details
Source
Drug Recall
External ID
D-0043-2024
Action Date
2023-10-25
Status
Terminated
Category
drug
Product Description
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
Lot/Code Info: Lot#s: 22DEC065 (MDU), exp: 09/29/2023; 23JAN024 (MDU), exp: 10/13/2023; 23FEB024 (SDU), exp: 11/09/2023; 23MAR013 (SDU), exp: 12/01/2023; 23MAR033 (SDU), exp: 12/16/2023; 23MAY044 (SDU), exp: 03/23/2024;
Quantity Affected: 6,228 bags + 15,360 boxes
Reason for Recall
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Distribution
Product was distributed to physician's offices nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-20
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 48 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-0043-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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