FDAFDA · Food and drugs·Recall number D-0488-2024
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
Published May 15, 2024 · Recall initiated: April 25, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TIMOLOL MALEATE
- Manufacturer
- FDC Limited
- Distributor
- New Jersey Only
- UPC
- 0364980513050
- Lot
- Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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