Reported May 15, 2024 · Terminated
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles…
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 · N/A
Is this the product you have?
- 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 byFDC Limited, Maharashtra, India
- Distributed byRising Pharmaceuticals, Inc, NJ
- Lot codes and dates
Lot #: a) 083H008Exp. Date 07/2025083G003Exp. Date 06/2025083J017Exp. Date 09/2025b) 083I013Exp. Date 08/2025
- Amount recalled
- 382,104 units
Where it was sold
Why it was recalled
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
This product could cause temporary or reversible health problems — stop using it.
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