Recalls / Class II
Class IID-0623-2024
Product
Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India.
- Brand name
- Ciprofloxacin
- Generic name
- Ciprofloxacin
- Active ingredient
- Ciprofloxacin Hydrochloride
- Route
- Ophthalmic
- NDC
- 69315-308
- FDA application
- ANDA077568
- Affected lot / code info
- Lot#: a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025.
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 N/A, India
Distribution
- Quantity
- 66,528 bottles
- Distribution pattern
- U.S. A. Nationwide
Timeline
- Recall initiated
- 2024-07-23
- FDA classified
- 2024-08-01
- Posted by FDA
- 2024-08-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0623-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.