FDA Drugs recall ·
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile… recall
- Recall number
- D-0182-2025
- Date
- (initiated December 16, 2024)
- Company / brand
- FDC Limited
B-8 MIDC Industrial Area, Aurangabad, Maharashtra State, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 136,181 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
Why was it 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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: 083L111, Exp. 11/30/2025; 084A032, Exp. 12/31/2025
Distribution
Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0182-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.