FDAHealthJanuary 23, 2025
FDC Limited — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals
⚠️ 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.
Is this relevant to me?
- Geography
- NJ
- Source agency
- FDA
- Category
- Health
- Published
- January 23, 2025
Distributed to one (1) Us Distributor in NJ
What's affected?
- Product
- 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.
- Brand
- TIMOLOL MALEATE
- UPC
- 0364980513050
- Lot code
- 083J033
Additional details
Lot#: 083J033, Exp. Date 09/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 118104 bottles.
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