D-0182-2025 Class II Ongoing
FDA drug recall D-0182-2025 was initiated by FDC Limited on December 16, 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: 136,181 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 15, 2025
- Initiation Date
- December 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 136,181 bottles
Product Description
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
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
Nationwide
Code Information
Lot: 083L111, Exp. 11/30/2025; 084A032, Exp. 12/31/2025