D-0632-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- August 21, 2024
- Initiation Date
- July 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 362,544 bottles
Product Description
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].
Reason for Recall
Defective container; yellow colored spike from cap lodged in the nozzle
Distribution Pattern
Nationwide in the US
Code Information
Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25