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
Reported: January 15, 2025 Initiated: December 16, 2024 #D-0182-2025
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
Details
- Recalling Firm
- FDC Limited
- Units Affected
- 136,181 bottles
- Distribution
- Nationwide
- Location
- Aurangabad, Maharashtra State
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by FDC Limited. Units affected: 136,181 bottles.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 15, 2025. Severity: Moderate. Recall number: D-0182-2025.
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