January 2025 FDA Recall Drug by Direct Rx
D-0364-2025 - Defective Container

This Class II drug recall was voluntarily initiated by Direct Rx on January 31, 2025 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed in Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID and the recall is currently ongoing.

Recall Number: D-0364-2025

Reason for Recall
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Initiated
01-31-2025
Reported
04-23-2025
Quantity
477 bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96573
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Direct Rx
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID
Product Description About Product Description
Full technical description of the product.
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.

Batch or Lot Expiration Information

Lot# Lot 11SE2402, Exp Date: 11/30/2025 Lot 14NO2406, Exp Date: 12/31/2025 Lot 29OC2420, Exp Date: 11/30/2025 Lot 30SE2412, Exp Date: 11/30/2025