Drug Enforcement D-0364-2025

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

Status

Ongoing

Classification

Class II

Report Date

April 23, 2025

Termination Date

—

Product Information

Product description
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
Product quantity
477 bottles.
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
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID

Location & Firm

Recalling firm
Direct Rx
Address
94 Worldwide Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0364-2025
Event ID
96573
Recall initiation date
January 31, 2025
Center classification date
April 15, 2025
Code info
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
More code info
—