Reported Dec 18, 2024 · Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj,…
FDC Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: FDC Limited · B-8 MIDC Industrial Area · Aurangabad, Maharashtra State · N/A
Is this the product you have?
- Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only
- Manufactured byFDC Limited, Waluj, Aurangabad, Maharashtra, India
- Distributed byRising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15
- Lot codes and dates
Lot #: 083I006Exp 08/31/2025
- Amount recalled
- 5184 bottles
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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