CIPROFLOXACIN HYDROCHLORIDE Recall D-0182-2025
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
CIPROFLOXACIN HYDROCHLORIDE Recall D-0182-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0182-2025 |
| Event ID | 96014 |
| Brand | CIPROFLOXACIN |
| Generic Name | CIPROFLOXACIN |
| Manufacturer | CIPROFLOXACIN |
| Original Package? | 1 |
| Active Substance | CIPROFLOXACIN HYDROCHLORIDE |
| Drug Route | OPHTHALMIC |
| Distribution | Nationwide |
| Quantity | 136,181 bottles |
| Recall Reason | 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 |
| Drug Classification | Class II |
| Drug Code Info | 20250115 |
| Product NDC | 69315-308 |
| Drug UPC | 0369315308028 0369315308059 |
| Recall Initiation Date | 20241216 |
| Report Date | 20250115 |
| Classification Date | 20250103 |
| Address | B-8 MIDC Industrial AreaWaluj District Aurangabad, Maharashtra State, N/A India |
| Recalling Firm | FDC Limited |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 4BA73M5E37 |
| Drug Application Number | ANDA077568 |
| Structured Product Labeling (SPL ID) | 8217ec14-6498-4c35-a5a9-511b451b9459 |
| Structured Product Labeling (SPL Set ID) | 545527e7-05c7-4dbf-ab32-b3fa463d55b0 |
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