FDAHealthJuly 18, 2024
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; yellow colored spike from cap lodged in the nozzle
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 18, 2024
Nationwide in the US
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
- 083J022
Additional details
Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 362,544 bottles.
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