Why it was 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.
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.
Lot numbers, UPCs & expiration codes
Lot#: a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025.
Where it was sold
U.S. A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0623-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 23, 2024
- FDA report date
- Aug 7, 2024
- Quantity
- 66,528 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- FDC Limited
Original FDA data
Every field from FDA enforcement report D-0623-2024, exactly as published.
Show all FDA fields
- City
- Aurangabad, Maharashtra State
- Status
- Ongoing
- Country
- India
- Event ID
- 95027
- Address
- B-8 MIDC Industrial Area
- Address (line 2)
- Waluj District
- Code information
- Lot#: a) 084C040, Exp 02/28/2026; b) 084A024, Exp12/31/2025.
- Report date
- Aug 7, 2024
- Product type
- Drugs
- Recall number
- D-0623-2024
- Classification
- Class II
- Recalling firm
- FDC Limited
- Product quantity
- 66,528 bottles
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- U.S. A. Nationwide
- Recall initiation date
- Jul 23, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 1, 2024