FDAFDA · Food and drugs·Recall number D-0642-2024
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
Published August 28, 2024 · Recall initiated: August 12, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TIMOLOL MALEATE
- Manufacturer
- FDC Limited
- Distributor
- Nationwide U.S.A.
- UPC
- 0364980513050
- Lot
- Lot #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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