Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West,
Summary
The FDA issued a Class III for Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, by Imprimis NJOF, LLC. Reason: Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range..
Details
Source
Drug Recall
External ID
D-1094-2023
Action Date
2023-08-30
Status
Terminated
Category
drug
Product Description
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.
Lot/Code Info: Lot #s: 22DEC047 exp 9/16/23, 23FEB057 exp 11/24/23.
Quantity Affected: 2,683 bottles
Reason for Recall
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-10
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 51 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-1094-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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