Why it was recalled
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Product description
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
Lot numbers, UPCs & expiration codes
Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.
Where it was sold
New Jersey Only
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-0488-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 25, 2024
- FDA report date
- May 15, 2024
- Quantity
- 382,104 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- FDC Limited
Original FDA data
Every field from FDA enforcement report D-0488-2024, exactly as published.
Show all FDA fields
- City
- Aurangabad, Maharashtra State
- Status
- Terminated
- Country
- India
- Event ID
- 94466
- Address
- B-8 MIDC Industrial Area
- Address (line 2)
- Waluj District
- Code information
- Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.
- Report date
- May 15, 2024
- Product type
- Drugs
- Recall number
- D-0488-2024
- Classification
- Class II
- Recalling firm
- FDC Limited
- Product quantity
- 382,104 units
- Termination date
- May 21, 2026
- Reason for recall
- Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
- Distribution pattern
- New Jersey Only
- Recall initiation date
- Apr 25, 2024
- Initial firm notification
- Letter
- Center classification date
- May 7, 2024