Status
Ongoing
Drug Enforcement D-0632-2024
Defective container; yellow colored spike from cap lodged in the nozzle
Classification
Class II
Report Date
August 21, 2024
Termination Date
—
Product Information
- 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].
- Product quantity
- 362,544 bottles
- Reason for recall
- Defective container; yellow colored spike from cap lodged in the nozzle
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the US
Location & Firm
- Recalling firm
- FDC Limited
- Address
-
B-8 MIDC Industrial Area, Waluj District
India - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0632-2024
- Event ID
- 94990
- Recall initiation date
- July 18, 2024
- Center classification date
- August 13, 2024
- Code info
- Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25
- More code info
- —