February 2025 FDA Recall Drug by Imprimis Njof, Llc
D-0305-2025 - Sub-Potent Drug

This Class III drug recall was voluntarily initiated by Imprimis Njof, Llc on February 24, 2025 for the product Drug. The FDA reported the reason for recall as sub-potent drug. The product was distributed in FL and NY and the recall is currently ongoing.

Recall Number: D-0305-2025

Reason for Recall
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Initiated
02-24-2025
Reported
04-09-2025
Quantity
2822 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96329
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.
Ongoing
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
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL and NY
Product Description About Product Description
Full technical description of the product.
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.

Batch or Lot Expiration Information

Lot# Lot 24OCT041, Exp 04/26/2025