Class II
Ongoing
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].
- Company
- Fdc Limited
- Recall Initiated
- July 18, 2024
- Posted
- August 21, 2024
- Recall Number
- D-0632-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 362,544 bottles
- Firm Location
- Aurangabad, Maharashtra State, India
Reason for Recall
Defective container; yellow colored spike from cap lodged in the nozzle
Distribution
Nationwide in the US
Lot / Code Info
Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25
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