FDA recall D-0053-2024
Pine Pharmaceuticals, LLC · Class II · drug
Product
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide within the United States
Key facts
- Status
- Terminated
- Initiation date
- 2023-10-02
- Report date
- 2023-10-25
- Termination date
- 2024-05-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Tonawanda, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0053-2024