FDAFDA · Food and drugs·Recall number D-0114-2025
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.
Published December 18, 2024 · Recall initiated: December 5, 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: 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
- Distributed to one Us Distributor in NJ.
- UPC
- 0364980513050
- Lot
- Lot #: 083I006, Exp 08/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.