Drug product
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
D-0364-2025
Product summary
- Firm
- Direct Rx
- Event
- Event 96573
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 477 bottles.
- Official record key
drug-enforcement:D-0364-2025
Official wording
Reason: 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
Code information: 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
Distribution pattern: Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID
Derived failure modes
-
Unknown
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