D-0623-2024 Class II Ongoing
FDA drug recall D-0623-2024 was initiated by FDC Limited on July 23, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 66,528 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 7, 2024
- Initiation Date
- July 23, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 66,528 bottles
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.
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.
Distribution Pattern
U.S. A. Nationwide
Code Information
Lot#: a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025.