Recalls / Class II
Class IID-0364-2025
Product
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
- Affected lot / 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
Why it was recalled
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
Recalling firm
- Firm
- Direct Rx
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 94 Worldwide Dr, Dawsonville, Georgia 30534-6828
Distribution
- Quantity
- 477 bottles.
- Distribution pattern
- Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID
Timeline
- Recall initiated
- 2025-01-31
- FDA classified
- 2025-04-15
- Posted by FDA
- 2025-04-23
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0364-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.