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
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.
Lot numbers, UPCs & expiration codes
Lot #: 083I006, Exp 08/31/2025
Where it was sold
Distributed to one Us Distributor in NJ.
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-0114-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 5, 2024
- FDA report date
- Dec 18, 2024
- Quantity
- 5184 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- FDC Limited
Original FDA data
Every field from FDA enforcement report D-0114-2025, exactly as published.
Show all FDA fields
- City
- Aurangabad, Maharashtra State
- Status
- Ongoing
- Country
- India
- Event ID
- 95921
- Address
- B-8 MIDC Industrial Area
- Address (line 2)
- Waluj District
- Code information
- Lot #: 083I006, Exp 08/31/2025
- Report date
- Dec 18, 2024
- Product type
- Drugs
- Recall number
- D-0114-2025
- Classification
- Class II
- Recalling firm
- FDC Limited
- Product quantity
- 5184 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
- Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.
- Distribution pattern
- Distributed to one Us Distributor in NJ.
- Recall initiation date
- Dec 5, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 6, 2024