Status
Completed
Drug Enforcement D-0488-2024
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Classification
Class II
Report Date
May 15, 2024
Termination Date
—
Product Information
- Product description
- Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
- Product quantity
- 382,104 units
- Reason for recall
- Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- New Jersey Only
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-0488-2024
- Event ID
- 94466
- Recall initiation date
- April 25, 2024
- Center classification date
- May 7, 2024
- Code info
- Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.
- More code info
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