Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, 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: March 26, 2025 Initiated: March 11, 2025 #D-0282-2025
Product Description
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, 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
- 90960 bottles
- Distribution
- Nationwide in the U.S
- Location
- Aurangabad, Maharashtra State, N/A
Frequently Asked Questions
What product was recalled? ▼
Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, 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: 90960 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 March 26, 2025. Severity: Moderate. Recall number: D-0282-2025.
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