Recalls / Class II
Class IID-0488-2024
Product
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
- Brand name
- Timolol Maleate
- Generic name
- Timolol Maleate
- Active ingredient
- Timolol Maleate
- Route
- Ophthalmic
- NDCs
- 64980-513, 64980-514
- FDA application
- ANDA077259
- Affected lot / code info
- Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.
Why it was recalled
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Recalling firm
- Firm
- FDC Limited
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- B-8 MIDC Industrial Area, Waluj District, Aurangabad, Maharashtra State, N/A N/A, India
Distribution
- Quantity
- 382,104 units
- Distribution pattern
- New Jersey Only
Timeline
- Recall initiated
- 2024-04-25
- FDA classified
- 2024-05-07
- Posted by FDA
- 2024-05-15
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0488-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.