FDAHealthAugust 12, 2024
FDC Limited — Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Auranga
⚠️ Defective Container: patients are 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
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 12, 2024
Nationwide U.S.A.
What's affected?
- Product
- Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey
- Brand
- TIMOLOL MALEATE
- UPC
- 0364980513050
- Lot code
- a)
Additional details
Lot #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 176,784 bottles.
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