Recalls / Class II
Class IID-0182-2025
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
- Brand name
- Ciprofloxacin
- Generic name
- Ciprofloxacin
- Active ingredient
- Ciprofloxacin Hydrochloride
- Route
- Ophthalmic
- NDC
- 69315-308
- FDA application
- ANDA077568
- Affected lot / code info
- Lot: 083L111, Exp. 11/30/2025; 084A032, Exp. 12/31/2025
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
- FDC Limited
- Manufacturer
- Leading Pharma, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- B-8 MIDC Industrial Area, Waluj District, Aurangabad, Maharashtra State, N/A, India
Distribution
- Quantity
- 136,181 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2024-12-16
- FDA classified
- 2025-01-03
- Posted by FDA
- 2025-01-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0182-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.