Why it was recalled
Defective Container: patients are 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%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey
Lot numbers, UPCs & expiration codes
Lot #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.
Where it was sold
Nationwide U.S.A.
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-0642-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 12, 2024
- FDA report date
- Aug 28, 2024
- Quantity
- 176,784 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- FDC Limited
Original FDA data
Every field from FDA enforcement report D-0642-2024, exactly as published.
Show all FDA fields
- City
- Aurangabad, Maharashtra State
- Status
- Ongoing
- Country
- India
- Event ID
- 95140
- Address
- B-8 MIDC Industrial Area
- Address (line 2)
- Waluj District
- Code information
- Lot #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.
- Report date
- Aug 28, 2024
- Product type
- Drugs
- Recall number
- D-0642-2024
- Classification
- Class II
- Recalling firm
- FDC Limited
- Product quantity
- 176,784 bottles
- Reason for recall
- Defective Container: patients are 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%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey
- Distribution pattern
- Nationwide U.S.A.
- Recall initiation date
- Aug 12, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 22, 2024