Status
Ongoing
Drug Enforcement D-0623-2024
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.
Classification
Class II
Report Date
August 7, 2024
Termination Date
—
Product Information
- Product description
- 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.
- Product quantity
- 66,528 bottles
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- U.S. A. Nationwide
Location & Firm
- Recalling firm
- FDC Limited
- Address
-
B-8 MIDC Industrial Area, Waluj District
India - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0623-2024
- Event ID
- 95027
- Recall initiation date
- July 23, 2024
- Center classification date
- August 1, 2024
- Code info
- Lot#: a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025.
- More code info
- —