August 2023 FDA Recall Drug by Imprimis Njof, Llc
D-1094-2023 - Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.

This Class III drug recall was voluntarily initiated by Imprimis Njof, Llc on August 10, 2023 for the product Drug. The FDA reported the reason for recall as subpotent drug; sub-potent bromfenac levels, below the 90.0-110.0% specification range.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1094-2023

Reason for Recall
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Initiated
08-10-2023
Reported
08-30-2023
Quantity
2,683 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92848
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Imprimis NJOF, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-22-2024
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# s: 22DEC047 exp 9/16/23, 23FEB057 exp 11/24/23.