FDC Limited: Drug Recall
Recall #D-0214-2025 · 01/23/2025
Class II: Risk
Recall Details
- Recall Number
- D-0214-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- FDC Limited
- Status
- Ongoing
- Date Initiated
- 01/23/2025
- Location
- Aurangabad, Maharashtra State, India
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 118104 bottles
Reason for Recall
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
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.
Distribution Pattern
Distributed to one (1) Us Distributor in NJ
Other Recalls by FDC Limited
- Class II: Risk 07/05/2025
- Class II: Risk 04/18/2025
- Class II: Risk 03/11/2025
- Class II: Risk 12/16/2024
- Class II: Risk 12/05/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.