FDAFDA · Food and drugs·Recall number D-0543-2025
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
Published August 6, 2025 · Recall initiated: July 5, 2025
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: spike of the cap becomes lodged in the nozzle of the product bottle.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TIMOLOL MALEATE
- Manufacturer
- FDC Limited
- Distributor
- U.S Nationwide.
- UPC
- 0364980513050
- Lot
- Lot#: 083L061, Exp.: 11/2025.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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