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.
Reported: August 7, 2024 Initiated: July 23, 2024 #D-0623-2024
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.
Details
- Recalling Firm
- FDC Limited
- Units Affected
- 66,528 bottles
- Distribution
- U.S. A. Nationwide
- Location
- Aurangabad, Maharashtra State, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by FDC Limited. Units affected: 66,528 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 August 7, 2024. Severity: Moderate. Recall number: D-0623-2024.
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