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, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
Lot numbers, UPCs & expiration codes
Lot #: 083L051, Exp. Date: 11/2025
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-0035-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 29, 2024
- FDA report date
- Nov 13, 2024
- Quantity
- 155,232 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- FDC Limited
Original FDA data
Every field from FDA enforcement report D-0035-2025, exactly as published.
Show all FDA fields
- City
- Aurangabad, Maharashtra State
- Status
- Ongoing
- Country
- India
- Event ID
- 95648
- Address
- B-8 MIDC Industrial Area
- Address (line 2)
- Waluj District
- Code information
- Lot #: 083L051, Exp. Date: 11/2025
- Report date
- Nov 13, 2024
- Product type
- Drugs
- Recall number
- D-0035-2025
- Classification
- Class II
- Recalling firm
- FDC Limited
- Product quantity
- 155,232 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, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
- Distribution pattern
- Distributed to one Us Distributor in NJ.
- Recall initiation date
- Oct 29, 2024
- Initial firm notification
- Letter
- Center classification date
- Nov 1, 2024